Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011050570

FEI Number

3011050570

Entity Name

Gyrus ACMI, Inc.

City/State/Country

Brooklyn Park, MN, US

Establishment Address

9600 Louisiana Ave North, Brooklyn Park, MN 55445, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OLYMPUS CORPORATION (Owner Number: 9067818)

Owner / Operator Contact Address

2951 ISHIKAWA-CHO, HACHIOJI-SHI, JP-13 192-8507, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252150

PMA Number

N/A

All Registered Proprietary Names

Ultrasil Sheehy-Type Collar Button Armstrong Bevelled Grommet Ultrasil Paparella Paparella Ultrasil Ultasil Richards T Tube Ultrasil Shepared Grommet Dolphin Collection Set Clip applier Thumb forceps Cotton applicator Tonsil forceps Laryngeal forceps Dressing forceps Needle holder Ear forceps Grasping forceps Pharyngeal forceps Biopsy forceps Towel forceps Gelfoam pressure forceps Swab forceps Turbinate forceps Septum forceps Punch forceps Adenoid forceps Nasal forceps TFL-FBX365R TFL-PLS Powered laser surgical instrument (TFL-AFSWL) TFL-FBX200BS TFL-FBX940R TFL-FBX365S TFL-CPLU TFL-SLS TFL-FBX150R TFL-FBX940S TFL-FBX550R TFL-FBX200S TFL-FBX550S TFL-FBX150BS TFL-FBX200R TFL-CSLU TFL-AFSW TFL-FBX150S Porous Hydroxylapatite Attic Defect McGee Off Center TORP Goldenberg PORP/TORP Black Oval TORP/PORP Shepard Grommet Tube Spoon-Bobbin Vent Tubes Dissector Tonsil dissector and retractor Woods Incus Stapes Goldenberg Incus Stapes Grote Incus Stapes Meyerhoff Incus Kartush Incus Stapes BIPOLAR COAGULATING FORCEPS SIF-Q180 Ti Bucket Handle Classic Stapes Pros. Tit. Shea Plat Cup Piston Lippy Mod Bucket Handle Titanium Richards Bucket Handle Titanium Richards BH Pros Flpl ALV-1 Double J Stent Iglesias Dissector Forceps PKS Dissectors Sheehy Weapon Sheehy Flap Knife ACMI Light Guide Adapters Killian Septum Speculum Buck Ear Currette Austin Tympanoplasty Richards Ritter-Halle Frontal Sinus Dilator Chest support Synergry Drill system Barnhill Adenoid Articulated arm and accessories Joseph Skin Hook Cottle Septum Speculum Bellucci Mic Scissors Double Spoon Biopsy Forceps RP Osteotome Delacruz measuring Russell-Davis Tongue Bld OTRP Trial Moriyama Univ. Cutt. Fcps Bojrab Dissector Black Oval Top Malony Mod PORP/TORP CYF-VHA CYF-5 CYF-VH MAJ-207 URO EZDilate BiCAP Hemorrhoid System MH-999E Plasma Cise Gyrus Urology Kit Gyrus Plasma V Plasma Cut Bantam Sm Chuck Handle Assy Endoscopic cord Adapter for Bovie Specialist Unit Vocom Vocal Cord Medial Shim Vocom Vocal Cord Mdlz MH-999E Vacuum-powered body fluid suction apparatus Irrigation Bag Spike Assy Model 1120 MR-6LA MR-6A Steritray OPTHALMIC CAUTERY, FINE TIP, STERILE VASECTOMY CAUTERY,ELONGATED TIP HT GVAP LOOP ELECTRODE (5 PACK) (VRS ANGLED LOOP RESECTOSCOPE ELECTRODE) GVAP ELECTRODE (5 PACK) (VRS RESECTOSCOPE ELECTRODE) OEV321UH CW-5 Smart Malleous Pistons Smart 360 Pistons Smart Stapes Pistons Smart Dela Cruz Pistons Cutting Forceps PKS Cutting Forceps Everest Adapter cord Disposable Bipolar Cord Model 2420 VISTA Hook Scissors HALO Fergusson Suction Richards Sinuscope Hajek Sphenoid Suction Irrigation Sheath Frontal Ostium Forceps Fiber Optic Light Cable Autoclavable scope Grasping Forceps Irrigating Blade Diamond Burrs Diego Blades Viper Mastoid Burrs Mastoid Round Cutting Burrs Dermabrader Stapes Cutting Burrs Burr CV-170 Invisio OLYMPUS STERILIZATION TRAYS Olympus KeyMed Instrument Tray A5961, A5976, A05951A, A05961A,WA05970A, WA05971A , WA05972A, WA05973A, WA05974A, WA05990A, WA05994A, WA05995A Versapoint WA94020A HF cable "EndoTherapy", monopolar ST-CR Cyberwand FB-225U FB-215U FB-245U FB-210K FB-221K FB-242U FB-230K FB-210U FB-214U FB-235U FB-224U FB-222U FB-41ST-1 FB-211K FB-240K FB-234U FB-244U FB-50U-1 FB-240U FB-231K FB-241K FB-220K FB-230U FLEXIBLE BIOPSY FORCEP FB-212U FB-232U FB-220U FB-26N-1 PJF-160 PK J-Hook Falope Ring Band Applicator Kits Falope Ring Band Model 1010 UroPass II UroPass MAJ-1453 MAJ-1119 MAJ-422 MAJ-1193 Leakage Tester Adapter Light-guide Adapter Cleaning Accessories FG-V431P FG-V422PR FG-V432P FG-45U-1 FG-V421PR Renal Dilator Stent/GW Combo Ureteral Catheter OEV262H TEL-GT Tray ENDO-ST Tray MRA-GT Tray FGT-1 Tray EAWE-N Hartmann Tuning Fork EU-ME1 EU-ME3 GF-UCT180 MAJ-1720 Endoscopic instrument sterilization trays Various sterilization trays Diego instrument sterilization tray Tray MAJ-1215 ASV1012 Varipass Variable Access Sheath Trapeze Ribbon Loop Grasping forceps Scissors E8218 Biopsy forceps DE Drill High Speed Drill Otoview scope Teleschi Suct ShockPulse ShockPulse POWERSEAL 2 Uropass Ureteral Access Sheaths Septum Needle Suction tupe BC-V600P-3010 CYB-2, CYB-3 Cord Gyrus PK Footswitch CW-4 Bovie generator HF-cables (reusable) Woodes Incudo Stapeidial joint Vokovic I-S Joint replacement plastipore Applebaum Incudo-stapedial PS-0021EJDA EBC05 EBC02 EBF02 EBF01 Everest Macro Bipolar Forceps Macro Bipolar Forceps Micro Bipolar Forceps Everest Micro Bipolar Forceps WOLF ADAPTER CORD Gauge pin G400 Workstation Telescope Instrument tray, for semi-rigid ureteroscope FTL-DEK-B BW-400V BW-403B MAJ-1339 BW-400B BW-411B BW-412T MAJ-1888 BW-400L Cleaning Accessory FTL-DEK-A Single Use Cleaning Brush Saw BLU Epistaxis Pack BLU Glide Nasal Pack BLU Nasal Pack PKS BiLL Protective Sheath InstaClear Light clip Light carrier Boucheron Ear Speculum Holmgren Speculum Hartmann Ear Speculum Politzer Ear Speculum Gruber Ear Speculum Speculum and accessories Autoclavable Scope Sinuscope OTV-SP1H-NA-12E OTV-S7H-1NA-12Q OTV-S7H-1NA-10E OTV-S7H-VA OTV-S7PROH-HD-12Q OTV-S7H-N OTV-S7H-1NA-12E LTF-S190-5 OTV-S7H-NA-12E OTV-S7H-1NA OTV-S7H-NA Pleatman Sac and accessories MAJ-1381 FG-52D FG-54D NA-201SX-4022 NA-201SX-4021 CH-S190-XZ-Q MAJ-2363 OTV-SI CV-1500 MAJ-2511 MAJ-2432 OTV-S200 OTV-S700 CLL-S700 MAJ-2512 CH-S700-XZ-EA CH-S190-08-LB Model 2220 Model 1200 21G EBUS Needle Gyrus G3 Generator Tilt-Top TORP Pros-Pls Sheehy TORP Shea Pls TORP Pros Shea Lg Hd Malleus Sheehy Modified TORP/PORP Pros E8213 GEN. SURGERY FORCEPS TB2-0535FC TB2-0520FC TB2-0525FC TB2-0545FC PBD-1030-1012 PBD-1030-0707 PBD-1030-1009 PBD-1030-0709 PBD-1030-1015 PBD-1030-0715 PBD-1030-0712 PBD-1030-1007 Syringe PK Lap Loop UCR Richards Pistons Piston Teflon/Wire Mangham Pistons Mass Eye and Ear Pistons Dela Cruz Pistons J PlasmaKnife Plasma J Hook Extender Cables Electrohydraulic Lithotripsy Probes Rasp Scoring instrument Raspatory Cartilage crusher Bone rongeur Cogent 1 Plasti-Pore Septal Button Silicone Septal Button VERSAPOINT GENERATOR BALL ELECTRODE (5 PACK) SPRING ELECTRODE (5 PACK) TWIZZLE ELECTRODE (5 PACK) FOOTSWITCH (SMALL) Foam head rest CF-H170I CF-H170L Double Pigtail MAJ-811 MAJ-843 Lowsley Electrode Blade Arthroscopes, CLV-S20 light source PKS Plasmaspatula Micro Bright Bivalve Splint Std Spetal Splint Std Neiman Sil RB Nasal Splint MAJ-686 PLASMA SECT UROLOGY Porous Hydroxlapatite granules Kartush Hydroxlapatite Disks PK Button Versapoint Plasmasord UltraCatch X-Catch SecurCatch SurLock Flatwire SurLock Grasping Forceps Sur-Catch Baskets SurLock Graspers VC-10 DTAD Lubri-Flex Stents Disposable Electrosurgical Pencil Otomimix Otologic cement Nephro EZDilate Balloon Catheter AIL-220 Light Source ENF-VH ENF-V3 OTV-S500 Mallet CyberWand MR-6A MR-6LA AUR-735 Biopsy Port Seals Accessory Kit NA-U401SX-4021 NA-U401SX-4022 Grote Canal Wall GW Lock POWERSEAL Hot Knives Vaportrode Loops Cold Knives 568618 Shepard Grommet Sheehy Collar Button Collar Button, Pacific Straight Vent Tube Reuter Bobbin, Pacific Armstrong Grommet IrriFlow EZDilate Silicone Single J TJF-Q170V PKS L-Hook Bilap L-Hook EIWE Endocapsule ChitoZolve Berger Bobbin Vent Tube Reut-Bob Vent Tubes Micron Bobbin Vent Tubes Fluoroplastic/Titanium Bobbin Micron Spoon Bobbin GY5-PCH TFL-AFC-NS, TFL-AFS150-NS, TFL-AFS200-NS, TFL-AFS365-NS, TFL-AFS550-NS, TFL-AFS940-NS Tip cleaner Holster 188 Duberstein applicator PK Cord PK generator SuperLoop SuperPulse generator SuperSect adapter Diego Trigger Console Diego Powered Dissector Diego Tube Set Diego Otology Tube Set Diego Model 2420 Lubri-Flex Telescope - autoclavable 20714 (HYSTEROSCOPE) GYNE-BR Invisio DUR-D BF-Q170 BF-1TQ170 FB-19SX-1 FB-221D FB-241D CLV-190 FB-231D Vocom Versapoint Dolphin II Transducer Tubing Dornhoffer Ti PORP Flex Grasper Wehrs Incus Protheses Wehrs II Incus Stapes Neutral electrode cable Probe Needle for Nerve Stimulator Stimulator Probe Pod Sur-Lock FG-52D FG-54D Shea PORP Goldenberg Cap Shea Cap Shea TORP Ear forceps, inserter for ventilation tubes Inserter, for T-Tubes UltraTrack Hybrid Guidewire Amplatz E-Z Glider Bentson Quadra Coil Stent/GW Combo Monopolar single-use HF cable PneumoLiner Powered Suction Pump Diego Elite Return Electrodes Cold Knives GVAP ELECTRODE (5 PACK) (VRS RESECTOSCOPE ELECTRODE) Frazier Suction Tube Baron Suction Tube Ferguson-Frazier Suction tube Verhoven Suction Tube Thunderbeat PK Diego Blades Diego Powered Dissectors Diego PK Console MAJ-528 Needle Sleeve Bending Tool Footswitch BICAP D-201-12704 D-201-10704 GIF-XP170N GIF-1TH190 GIF-H170 D-201-11804 D-201-15004 USG-410 TD-410 MAJ-2467 TB2-0535FC TB2-0520FC TB2-0545FC TB2-0525FC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2008-06-17
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2008-06-17
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2016-02-22
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2008-03-06
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2008-03-03
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2023-11-16
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-12-11
ETC	Mold, Middle-Ear	Ear, Nose, Throat	Class 2	874.3430	2008-03-03
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2008-03-03
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2008-03-06
KBM	Dissector, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2023-11-16
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-08-28
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2022-03-28
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-06
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2012-10-22
GCT	Light Source, Endoscope, Xenon Arc	Gastroenterology, Urology	Class 2	876.1500	2012-10-22
FFS	Image, Illumination, Fiberoptic, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2012-10-22
FCR	Light Source, Photographic, Fiberoptic	Gastroenterology, Urology	Class 2	876.1500	2012-10-22
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2012-08-28
FDC	Resectoscope, Working Element	Gastroenterology, Urology	Class 2	876.1500	2008-03-06
FBO	Cystourethroscope	Gastroenterology, Urology	Class 2	876.1500	2008-03-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	2023-11-16
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-03-05
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2008-03-03
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2008-03-11
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-03-28
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2013-11-26
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2013-11-26
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2009-03-09
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2012-10-22
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2006-01-31
FGA	Kit, Nephroscope	Gastroenterology, Urology	Class 2	876.1500	2006-01-31
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2006-01-31
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2006-01-31
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2010-06-24
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2008-03-03
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-03-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-07
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	Class 2	874.3620	2008-03-03
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2006-12-01
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2006-12-01
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2006-12-01
FGA	Kit, Nephroscope	Gastroenterology, Urology	Class 2	876.1500	2006-12-01
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2006-12-01
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2006-12-01
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2008-03-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2007-11-30
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2007-11-30
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-03-11
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2023-11-14
HQP	Unit, Cautery, Thermal, Battery-Powered	Ophthalmic	Class 2	886.4115	2016-09-27
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2008-03-04
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2008-03-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-03-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2007-11-30
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2008-03-05
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2008-03-05
MND	Ligator, Esophageal	Gastroenterology, Urology	Class 2	876.4400	2008-06-17
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2023-10-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
FNS	Ring Cutter	General Hospital	Class 1	880.6200	2012-10-22
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2012-10-22
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-04-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-03-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-07-22
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2012-09-17
GCM	Endoscope, Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-03-03
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2008-03-03
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2025-06-17
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-10-22
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2023-11-10
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2014-05-22
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2014-05-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-15
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-10-22
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	Class 2	876.4480	2014-02-04
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2013-08-08
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2008-03-03
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-12-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-01-09
KNH	Laparoscopic Contraceptive Tubal Occlusion Device	Obstetrics/Gynecology	Class 3	884.5380	2008-03-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2012-11-02
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	1995-01-20
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2022-04-04
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2008-03-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-02-28
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2008-03-05
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2008-03-03
EWA	Set, Audiometer Calibration	Ear, Nose, Throat	Class 1	874.1080	2012-10-22
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-10-30
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2008-03-03
FEO	Lithotriptor, Ultrasonic	Gastroenterology, Urology	Class 2	876.4480	2007-11-30
KNY	Accessories, Catheter, G-U	Gastroenterology, Urology	Class 2	876.5130	2013-09-11
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-06
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2008-03-03
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2016-06-21
EWA	Set, Audiometer Calibration	Ear, Nose, Throat	Class 1	874.1080	2008-03-03
FEO	Lithotriptor, Ultrasonic	Gastroenterology, Urology	Class 2	876.4480	2019-07-12
FEO	Lithotriptor, Ultrasonic	Gastroenterology, Urology	Class 2	876.4480	2014-12-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-12-11
KNY	Accessories, Catheter, G-U	Gastroenterology, Urology	Class 2	876.5130	2008-03-05
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2023-11-16
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2007-11-30
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2009-07-15
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-06-17
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-06-17
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2008-06-17
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-06-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-10-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-15
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-04-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-27
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	2023-11-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-04
HEW	Culdoscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1640	2012-09-17
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2023-11-15
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2008-03-03
KBC	Saw, Nasal	Ear, Nose, Throat	Class 1	874.4420	2023-11-16
LQC	Lithotriptor, Biliary Mechanical	Gastroenterology, Urology	Class 2	876.4500	2007-12-10
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2011-11-21
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-10-20
HIN	Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4150	2012-12-10
OCU	Endoscopic Storage Cover	Gastroenterology, Urology	Class 2	876.1500	2012-10-22
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2016-01-15
MQW	Transilluminator, Fiber Optic	Ear, Nose, Throat	Class 1	874.4350	2023-11-16
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2008-03-03
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2008-03-07
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-03-28
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-03-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-12-11
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2013-07-25
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2013-07-25
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2025-04-07
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-07-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2018-07-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-03
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2008-03-06
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-03-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-04-03
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2024-06-07
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2010-04-20
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2010-04-20
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2007-12-10
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2023-11-16
HIN	Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4150	2023-11-14
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-01-16
JAB	System, X-Ray, Fluoroscopic, Non-Image-Intensified	Radiology	Class 2	892.1660	2008-01-16
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2008-06-16
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2024-09-27
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2008-06-17
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	Class 2	876.4480	2008-03-03
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2023-11-16
KBB	Rongeur, Nasal	Ear, Nose, Throat	Class 1	874.4420	2023-11-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
FZE	Prosthesis, Nose, Internal	General, Plastic Surgery	Class 2	878.3680	2008-03-03
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2008-03-04
EPW	Support, Head, Surgical, Ent	General, Plastic Surgery	Class 1	878.4950	2018-12-11
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-07-29
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2012-11-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-06-16
KOB	Catheter, Suprapubic (And Accessories)	Gastroenterology, Urology	Class 2	876.5090	2008-03-05
JOS	Electrode, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2008-03-05
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2008-06-16
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-11-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
FSQ	Light, Surgical, Instrument	General, Plastic Surgery	Class 2	878.4580	2008-03-03
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2008-03-03
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2008-03-03
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2006-12-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2006-12-01
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2008-03-04
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2008-03-04
FDC	Resectoscope, Working Element	Gastroenterology, Urology	Class 2	876.1500	2008-03-04
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2008-03-04
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2008-03-03
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2008-06-19
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2010-04-13
HIN	Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4150	2014-06-09
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2014-06-09
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	1995-08-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-06-19
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2008-06-19
FGO	Dislodger, Stone, Flexible	Gastroenterology, Urology	Class 2	876.4680	2008-03-03
HHI	System, Abortion, Vacuum	Obstetrics/Gynecology	Class 2	884.5070	2022-03-10
HHK	Curette, Suction, Endometrial (And Accessories)	Obstetrics/Gynecology	Class 2	884.1175	2022-03-10
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2024-01-19
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2012-11-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-01
NEA	Cement, Ear, Nose And Throat	Dental	Class 2	872.3275	2008-03-03
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2008-12-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-12-11
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2008-12-11
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-12-11
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2014-05-30
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2008-03-05
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2022-03-28
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2023-11-16
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	Class 2	876.4480	2015-12-07
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-03-04
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-03-05
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2016-11-16
FZD	Prosthesis, Ear, Internal	General, Plastic Surgery	Class 2	878.3590	2013-12-03
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2019-04-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-09-15
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2008-03-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-10-22
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2012-09-17
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2008-03-05
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2018-06-20
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2018-06-20
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2012-11-02
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-07-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
FBO	Cystourethroscope	Gastroenterology, Urology	Class 2	876.1500	2008-03-06
NEZ	System, Imaging, Gastrointestinal, Wireless, Capsule	Gastroenterology, Urology	Class 2	876.1300	2016-02-10
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2018-12-11
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2018-12-11
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2008-03-06
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2015-02-27
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2008-03-03
KQT	Evacuator, Gastro-Urology	Gastroenterology, Urology	Class 2	876.4370	2008-03-03
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2008-03-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-10-22
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2008-03-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-03
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2006-12-01
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-10-30
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2012-11-02
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2014-01-31
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2012-10-22
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-03-04
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-03-04
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2021-07-29
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2007-11-30
MIX	System, Vocal Cord Medialization	Ear, Nose, Throat	Class 2	874.3620	2008-03-03
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2023-10-20
HDB	Extractor, Vacuum, Fetal	Obstetrics/Gynecology	Class 2	884.4340	2023-10-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-01-11
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2017-01-11
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2014-06-09
HFI	Coagulator, Culdoscopic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2014-06-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-06-17
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2008-06-17
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2009-07-27
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2012-09-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-05
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-15
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2010-01-22
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2008-03-05
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2008-03-06
JYM	Inserter, Myringotomy Tube	Ear, Nose, Throat	Class 1	874.4420	2023-11-16
EYA	Stylet, Ureteral	Gastroenterology, Urology	Class 1	876.5130	2013-01-09
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2008-03-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-15
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2008-06-17
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2008-06-16
PMU	Containment System, Laparoscopic Power Morcellation, With Instrument Port	Obstetrics/Gynecology	Class 2	884.4050	2023-11-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-04-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-03-09
EZO	Urethrotome	Gastroenterology, Urology	Class 2	876.4770	2008-03-03
HFG	Coagulator, Laparoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2008-03-07
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2008-03-07
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2018-04-01
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2018-04-01
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2008-03-03
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2015-04-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-04-05
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2008-03-11
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2008-01-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-06-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-12-11
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2008-06-17
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2012-10-22
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-07-29
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2025-11-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-11-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011050570. Last updated year: 2026. Please use registration number 3011050570 when referencing this establishment in official correspondence.