Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003790304

FEI Number

3003790304

Entity Name

GYRUS ACMI, INC.

City/State/Country

Westborough, MA, US

Establishment Address

800 West Park Drive, Westborough, MA 01581, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K760437

PMA Number

N/A

All Registered Proprietary Names

Uro Guide Perc Antegrade ureteral stent 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 URO EZDilate Grasping forceps Scissors E8218 Biopsy 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 Foam head rest IrriFlow McGee Off Center TORP Goldenberg PORP/TORP Black Oval TORP/PORP UltraCatch X-Catch SecurCatch SurLock Flatwire SurLock Grasping Forceps Sur-Catch Baskets SurLock Graspers EAWE-N GW Lock Ultrasil Sheehy-Type Collar Button Armstrong Bevelled Grommet Ultrasil Paparella Paparella Ultrasil Ultasil Richards T Tube Ultrasil Shepared Grommet AUR-735 Biopsy Port Seals Accessory Kit Nephro EZDilate Balloon Catheter 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 Model 2220 Model 1200 Extender Cables Electrohydraulic Lithotripsy Probes Porous Hydroxylapatite Attic Defect Cogent 1 Richards Pistons Piston Teflon/Wire Mangham Pistons Mass Eye and Ear Pistons Dela Cruz Pistons Univ Ext Nasal Splint AF Nasal Splint Wide Line Nasal Pack 70140095 70890735 Slim Line Nasal Pack 70890732 70890738 70890730 70890737 70890751 70890739 70890743 70890742 70890753 70890740 70890752 70890734 70890728 70890733 70890754 70890731 70890756 70890729 70890750 70890741 70890755 70890757 Telescope GY5-PCH IBV Valve System IBV Valve VC-10 Frazier Suction Tube Baron Suction Tube Ferguson-Frazier Suction tube Verhoven Suction Tube Model 1010 Fixed Wire EZDilate 3-Stage Balloon Dilation Catheter MAJ-1453 MAJ-1119 MAJ-422 MAJ-1193 Leakage Tester Adapter Light-guide Adapter Cleaning Accessories Sof-Curl Multi-Flex Double J II Cutting Forceps PKS Cutting Forceps Everest Adapter cord TFL-AFC-NS, TFL-AFS150-NS, TFL-AFS200-NS, TFL-AFS365-NS, TFL-AFS550-NS, TFL-AFS940-NS Tip cleaner Holster Duberstein applicator E-Z Grip Guidewire Torque Device Wehrs Incus Protheses Wehrs II Incus Stapes Jahn Tube Hydroxlapatite Jahn Hydroxlvent Celeris Invisio Black Oval Top Malony Mod PORP/TORP Quadra Coil Stent/GW Combo Diego Spine Zimmer Diego Spine Autoclavable Scope Sinuscope Diego Trigger Console Diego Powered Dissector Diego Tube Set Diego Otology Tube Set Diego Bantam Sm Chuck Handle Assy Endoscopic cord Adapter for Bovie Specialist Unit Plasti-Pore Septal Button Silicone Septal Button Fergusson Suction Richards Sinuscope Hajek Sphenoid Suction Irrigation Sheath Frontal Ostium Forceps Shea PORP Goldenberg Cap Shea Cap Shea TORP PKS BiLL Powered Suction Pump Diego Elite Aspiration needle Hot Knives Vaportrode Loops Cold Knives Uropass Ureteral Access Sheaths Fulgurating Electrode Elite 2 System Reusable Active Cord Roller Electrode Stabilized Cutting Loops McCarthy Electrode Invisio DUR-D InstaClear MR-6A MR-6LA Double J Stent Trapeze Ribbon Loop Grote Canal Wall ShockPulse Diego Universal Adaptor Diego Starlink Handpiece Gyrus G3 Generator Plasma Cise Gyrus Urology Kit Gyrus Plasma V Plasma Cut ShockPulse Cord Gyrus PK Footswitch Shepard Grommet Tube Spoon-Bobbin Vent Tubes MR-6LA MR-6A Silicone Single J Otoview scope Teleschi Suct DE Drill High Speed Drill Schuring Ossicle Columella Centered PORP/TORP Austin Modified TORP Spanner Strut Off-Centered PORP/TORP Dornhoffer Footplates Boucheron Ear Speculum Holmgren Speculum Hartmann Ear Speculum Politzer Ear Speculum Gruber Ear Speculum Speculum and accessories Lubri-Flex Stents Vocom Vocal Cord Medial Shim Vocom Vocal Cord Mdlz Double Pigtail Footswitch Return Electrodes Tilt-Top TORP Pros-Pls Sheehy TORP Shea Pls TORP Pros Shea Lg Hd Malleus Sheehy Modified TORP/PORP Pros CyberWand Shepard Grommet Sheehy Collar Button Collar Button, Pacific Straight Vent Tube Reuter Bobbin, Pacific Armstrong Grommet EIWE EBC05 EBC02 EBF02 EBF01 Everest Macro Bipolar Forceps Macro Bipolar Forceps Micro Bipolar Forceps Everest Micro Bipolar Forceps WOLF ADAPTER CORD TEL-GT Tray ENDO-ST Tray MRA-GT Tray FGT-1 Tray Woods Incus Stapes Goldenberg Incus Stapes Grote Incus Stapes Meyerhoff Incus Kartush Incus Stapes OPTHALMIC CAUTERY, FINE TIP, STERILE VASECTOMY CAUTERY,ELONGATED TIP HT Micron II CTR TORP Monolithic All Titanium Micron II OCTR All Titanium TORP Micron II CTR PORP Monlithic All Titanium Adj. Micron Ti TORP Micron II OCTR PORP Monolithic All Titanium Endoscopic instrument sterilization trays Various sterilization trays Diego instrument sterilization tray Tray Model 1120 Occular Occluder Micro instrument wipe Shah Aural dressing universal Rosette Packing Blu Ear Wick Dual Lumen Catheter ChitoZolve Shepard Grommet Vent Tube Spoon-Bobbin Vent Tube Turner Drain Tube Pope Beveled Grommet Reut-Bob Vent Tube PK Diego Blades Diego Powered Dissectors Diego PK Console Applebaum Incus Replacement Grote Incus Prothesis Kartush Incus Strut Goldenberg Incus Prosth. Protective Sheath Vocom Plasmasord ASV1012 Varipass Variable Access Sheath ST-CR Irrigating Blade Diamond Burrs Diego Blades Viper Mastoid Burrs Mastoid Round Cutting Burrs Dermabrader Stapes Cutting Burrs Burr G400 Workstation Renal Dilator Stent/GW Combo Ureteral Catheter Causse Piston Fluoroplastic Piston Classic Stapes Prosthesis Arrigg II Piston

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2012-11-02
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2008-03-03
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
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2008-03-03
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-12-11
EPW	Support, Head, Surgical, Ent	General, Plastic Surgery	Class 1	878.4950	2018-12-11
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2008-03-05
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2008-03-03
FGO	Dislodger, Stone, Flexible	Gastroenterology, Urology	Class 2	876.4680	2008-03-03
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2008-03-03
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2019-04-10
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2008-03-06
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-03-05
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2014-05-30
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2008-03-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	Class 2	876.4480	2008-03-03
ETC	Mold, Middle-Ear	Ear, Nose, Throat	Class 2	874.3430	2008-03-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-03
EPP	Splint, Nasal	Ear, Nose, Throat	Class 1	874.5800	2008-03-03
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2008-03-03
HEW	Culdoscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1640	2012-09-17
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2015-02-27
NJK	Valve, Pulmonary	Unknown	Class 3	N/A	2019-03-27
OAZ	One-Way Air-Leak Valve	Unknown	Class f	N/A	2010-08-23
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
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2008-03-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2015-04-01
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	1995-01-20
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2012-11-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2008-03-03
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2008-03-03
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-08-28
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-06
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2008-03-11
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2022-01-28
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-10-22
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2008-03-11
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2008-03-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2009-02-12
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2008-03-07
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	2008-03-07
FZE	Prosthesis, Nose, Internal	General, Plastic Surgery	Class 2	878.3680	2008-03-03
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2012-09-17
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2008-03-06
HIN	Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4150	2012-12-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-04-09
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2022-03-10
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2022-03-10
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2008-03-03
KNY	Accessories, Catheter, G-U	Gastroenterology, Urology	Class 2	876.5130	2008-03-05
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	2008-03-04
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-03-04
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2016-01-15
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-03-04
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2012-08-28
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-06
FZD	Prosthesis, Ear, Internal	General, Plastic Surgery	Class 2	878.3590	2013-12-03
FEO	Lithotriptor, Ultrasonic	Gastroenterology, Urology	Class 2	876.4480	2014-12-23
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2008-03-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-03
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
FEO	Lithotriptor, Ultrasonic	Gastroenterology, Urology	Class 2	876.4480	2019-07-12
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2009-07-15
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2008-03-06
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-03-11
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2012-11-02
EWA	Set, Audiometer Calibration	Ear, Nose, Throat	Class 1	874.1080	2008-03-03
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2016-06-21
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-06
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2008-03-03
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2012-11-02
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	Class 2	874.3620	2008-03-03
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2012-11-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-12-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-03-09
LMB	Device, Digital Image Storage, Radiological	Radiology	Class 1	892.2010	2012-10-22
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2008-03-06
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	Class 2	876.4480	2015-12-07
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2012-09-17
FBO	Cystourethroscope	Gastroenterology, Urology	Class 2	876.1500	2008-03-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-27
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2008-03-05
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-11
HQP	Unit, Cautery, Thermal, Battery-Powered	Ophthalmic	Class 2	886.4115	2016-09-27
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2012-09-17
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2012-09-17
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2008-03-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2008-03-03
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2012-10-22
KCN	Ear Wick	Ear, Nose, Throat	Class 1	874.5220	2008-03-03
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2012-10-22
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
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2008-03-11
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-06
OCU	Endoscopic Storage Cover	Gastroenterology, Urology	Class 2	876.1500	2012-10-22
MIX	System, Vocal Cord Medialization	Ear, Nose, Throat	Class 2	874.3620	2008-03-03
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
KNY	Accessories, Catheter, G-U	Gastroenterology, Urology	Class 2	876.5130	2013-09-11
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-10-22
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2008-03-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-04
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2008-03-05
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2021-02-01
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OLYMPUS CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003790304. Last updated year: 2026. Please use registration number 3003790304 when referencing this establishment in official correspondence.