Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010707607

FEI Number

3010707607

Entity Name

KARL STORZ SE & CO. KG

City/State/Country

NEUHAUSEN OBECK Baden-Wurttemberg, DE

Establishment Address

TAKE-OFF GEWERBEPARK 83, NEUHAUSEN OBECK Baden-Wurttemberg 78579, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

KARL STORZ SE & CO KG (Owner Number: 8010119)

Owner / Operator Contact Address

Dr.-Karl-Storz-Strasse 34,, TUTTLINGEN, DE-BW 78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Trans-Nasal Esophagoscopes Micro Surgical Instruments SACHSE DRILL Instrument Tray Nasopharyngoscope Mono High Freq Cords Endomat Select (Model Number: UP210) Karl Storz Arthropump Power Irrigation/Suction Pump, Tubing Cleaning Brushes and kits GAAB Rigid NEUROENDOSCOPES REMORGIDA Forceps ENT Stent Applicator Forceps HD-View VACUSAFE TUBING SETS DCI Endoscope Flexible Hysteroscope, 10.5 Fr THERMOFLATOR, Model 26 4320 20 KARL STORZ FIBEROPTIC Flexible CMOS Video-Cysto Urethroscope FISCH Titanium Mid Ear Prostheses FISCH TITANIUM MID Vaporization Electrodes Chair and Table, Medical Insulated Dissecting Cannulae Neuroscope and Accessories CALCUSPLIT KARL STORZ Bipolar Resectoscopes with HF Cable AUTOCON II 400 Electrosurgical Gen. Spinoscope Insulated Biopsy Forceps Flexible Trocar Sleeves Sialoendoscopes and Accessories Model 27080 LITHOTRIPTOR System HAMOU ENDOMAT Disposable Tubing Set Grasping, Biopsy, and Spoon Forceps General/Plastic Surgery Instruments manual surgical instrument ENT Semi-Rigid Microendoscope & Acc. New Generation Trocars Flexible Choledochoscope Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories Continuous Flow Cystoscope KARL STORZ OTOSCOPE OTOSCOPE Tuning Fork Uterine Manipulator Video Flexible ENT Endoscope System HYDROMAT, Model 263110 20 Trocars, Cannulae and Sheaths Suction/Irrigation Tubes Arthroforce SilCut Shoulder Pro SilGrasp KARL STORZ BLADDER EVACUATOR Retractors,Probes,Dissectors,Hooks KARL STORZ Mediastinoscopes and Instruments KARL STORZ NAV1 Electromagnetic Navigation System KARL STORZ NEEDLE HOLDERS Nonpowered neurosurgical instrument KARL STORZ SURGICAL CANNULA AIDA Compact II System ADVANCED IMAGE AND DATA Monopolar Coagulating Electrodes Bipolar Electrodes Arthroscopic Telescopes Scissors, ENDO/LAP Headband Headlight Telescpes, Rigid/Mgnifying/KS VARIA Navigation Panel Unit Protoscopes, Sigmoidoscopes, Acc. MTP Disposable Trocar Valves Laryngoscope Accessories CLICKLINE Scissors Inserts for single use Series 11274 Flex. URETEROSCOPE SCB/STERIS OR-Light Interface Box Insufflation Bulb ENT Rigid Telescopes Trocars, Cannulae and Sheaths Micro-Instrum. for Cochlear Implant Smoke Removal Tube S-Pilot Infant Balloon VAGINOSCOPES ARTHRO PUMP Basin for endoscope reprocessing Light source system, diagnostic endoscopic Cold Knife Blades Plastic Surgery Accessories Autocon II 400 Electrosurgical Gen Endoscope DCI Endoscope Speculum, ENT Take-Apart Scissors Dental Hand Instruments Esophagoscope and Accessories Semi-Rigid Micro-Endoscpes & Acc. AIDA w/ DICOM and HL7 Interface Snares CALCUSON DCI VIDEO LARYNGOSCOPE MIrror KARL STORZ PULSAR II Modification to ENDOTIP System S-Pilot Catheters, MANDRIN, Plugs, Connect Take Apart Rotating Grasping Forcep KARL STORZ ENDOVISION HYSTEROCAM KARL STORZ ENDOVISION UROCAM KARL STORZ HYSTEROCAM Powershaver System S2 KARL STORZ Shuntscope Bronchoscopes Insulated ELECTROSUGRICAL Instrum. EQUIMAT, Model 203020 20 TIPCAM 1S 3D System GELET Uretero-Renoscope Intra-Handpieces & Accessories Sterilization Trays Mono Coag Needle, Loop Electrodes Mono Coag Needle Electrode Flexible Video-Uretero-Renoscope Flex-XC Ureter Resectoscope Suction Catheters HYSTEROSCOPIC INSU LED light source Endoscopy Instrument Saphenous Vein Harvesting Set Powder Blower and Accessories Dental Endoscopes Large Joint Arthroscopy Set Wound Closure Instruments Sunction Tube Light Cable Dilators, Reducers, Sleeves KARL STORZ Endoscopic ICG Imaging System UNIMAT Plus Operating LARYNGOSCOPES & Accs TUBING SET FOR LAPAROSCOPIC INSUFFL TUBING ENDOFLATOR + Cover Laproscope Rotocut G1 Morcellator, Electromech Rigid Telescopes Monopolr Cord, Endoscpc Hi-Frequncy Catheters Hysteroscope and accessories KSEA Monopolar Resectoscopes Obturators, Cannula Sheaths KARL STORZ LARYNGOSCOPE Semi-rigid Hysteroscope Telescope Bridges & Adaptors CO2 HYDROMAT Pump for Irrigation KARL STORZ HOPKINS Telescopes for Urology Image 1 SPIES Semi-Rigid Microendoscope & Acc. UROMAT Deployable Cardiovascular Clamp Neuro FIBERSCOPE DCI Endoscope Forceps, ENDO/LAP Power LED 175 Light Fountain Light Fountain 50 Watts Puncture, Injction, ENDOSCPIC VERES ENDOFLATOR 40&50 Model 27224P Continuous Flow Pump Insulated Dissecting Cannulae Adaptors for Documentation Endoscope Holder URETERO-RENOSCOPES/URETEROSCOPE HOPKINS I/II Autoclavable Telescope MOUTH GAG UNIMAT 12 ENDOSPINE Oper Tube & Telesc Bridge HARTMANN Ear Speculum KNIFE, ENT MAHNES Take-Apart Bipol Coag Forcep Microcast HD Pro Microcast 4K Pro VITOM Unidrive SIII ENT Xenon Nova Light Source KARL STORZ Endoscopic Accessories for Urology KARL STORZ ICG Imaging System KOH Needle Holders, Suture Forceps MTP CLEARVISION Disp Tubing Set ENT Surgical Instrument SCB/VALLEY LAB Force FX Interface Nasopharyngo/Broncho/Tracheoscopes UNIDRIVE SIII System SCB-RUI (Realistic User Interface) Mono Ball/Needle/Loop Electrodes Medicine Cups VOICE1 SCB R-UI Speech Control App ARTHROPUMP DISP, Tubing Set Contact Microlaryngoscope SPIES 3D System CLEARVISION Lens Irrigation System KSEA CLEARVISION LE 11274AB Flex Pediatric BRONCHOSCOPE Retractors,Probes,Dissectors,Hooks Model 27086C Ultrasonic LITHOTRITE KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S MTP ARTHROUMP TUBING SET Bridges, Adaptors Rhino-Laryngo-Bronco Fiberscope SAWAHLE Electromech. Morcellator Take-Apart Bipolar Forceps RHINO-PHARYNGO-LARYNGO FIBERSCOPE Take-Apart Forceps EQUIMAT Model 203020 20 Optical Mediastinoscope Flexible CHOLEDOCHOSCOPE Semi-Rigid Micro-Endoscpes & Acces. Nephroscope, Adult & Pediatric LED Headlight KS70 Resectoscopes STEINER Electromechanic Morcellator KARL STORZ FORCEPS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EOX	Esophagoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4710	2007-10-18
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2009-09-15
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2004-01-02
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2008-10-09
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2007-10-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-20
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2018-11-20
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2018-11-20
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2018-11-20
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2018-11-20
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2018-11-20
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2018-11-20
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2010-12-20
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2011-01-18
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2007-11-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-21
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2007-11-20
FBO	Cystourethroscope	Gastroenterology, Urology	Class 2	876.1500	2019-04-24
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-04-24
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2020-03-12
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2007-11-14
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2007-12-03
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2007-11-20
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2001-02-02
FBO	Cystourethroscope	Gastroenterology, Urology	Class 2	876.1500	2014-01-03
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2006-09-01
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2006-09-01
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2007-06-20
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2017-06-12
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-11-20
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2007-11-20
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2007-10-24
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	Class 2	876.4480	2007-11-12
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2023-04-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-04-06
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2023-04-06
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2023-04-06
FDC	Resectoscope, Working Element	Gastroenterology, Urology	Class 2	876.1500	2023-04-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-10-24
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2007-10-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-10-24
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	Class 2	876.4480	2007-11-14
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-11-14
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2007-11-14
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2007-11-14
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2009-06-12
FGC	Urethroscope	Gastroenterology, Urology	Class 2	876.1500	2007-11-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2018-07-23
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2007-11-19
FBO	Cystourethroscope	Gastroenterology, Urology	Class 2	876.1500	2009-03-24
FBO	Cystourethroscope	Gastroenterology, Urology	Class 2	876.1500	2007-11-19
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	1999-08-10
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2015-06-24
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2007-10-24
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2007-10-18
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-11-08
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-20
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2014-03-19
FFD	Evacuator, Bladder, Manually Operated	Gastroenterology, Urology	Class 1	876.4370	2001-02-05
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-11-20
EWY	Mediastinoscope, Surgical	Ear, Nose, Throat	Class 2	874.4720	2026-03-09
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2016-12-06
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1999-08-10
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2009-11-13
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2001-02-07
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2006-09-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-08
HIN	Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4150	2013-07-31
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2007-11-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-14
FSR	Light, Headband, Surgical	Ophthalmic	Class 2	886.4335	2016-02-28
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2007-11-14
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2013-03-13
FAM	Sigmoidoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2007-11-20
GCF	Proctoscope	Gastroenterology, Urology	Class 2	876.1500	2007-11-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-03
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2007-11-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-10-16
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2007-11-14
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2007-10-19
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2015-06-23
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2007-11-20
ENZ	Telescope, Laryngeal-Bronchial	Ear, Nose, Throat	Class 2	874.4680	2007-11-20
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2007-11-19
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-11-19
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2007-11-20
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2007-11-20
FCZ	Tube, Smoke Removal, Endoscopic	Gastroenterology, Urology	Class 1	876.1500	2015-06-23
MOK	Vaginoscope And Accessories	Obstetrics/Gynecology	Class 2	884.1630	2007-11-20
HRX	Arthroscope	Orthopedic	Class 2	888.1100	1999-08-10
PHT	Basin For Endoscope Reprocessing	Gastroenterology, Urology	Class 1	876.1500	2021-12-21
OAY	Light Source System, Diagnostic Endoscopic	Unknown	Class 3	N/A	2010-09-16
EZO	Urethrotome	Gastroenterology, Urology	Class 2	876.4770	2007-11-14
GCM	Endoscope, Rigid	Gastroenterology, Urology	Class 2	876.1500	2007-11-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-10-18
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2007-11-14
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2007-11-14
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2017-05-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-20
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2011-08-24
EOX	Esophagoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4710	2007-11-19
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-11-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2007-10-19
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2007-10-19
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2007-11-20
FEO	Lithotriptor, Ultrasonic	Gastroenterology, Urology	Class 2	876.4480	2007-11-09
CAL	Laryngoscope, Non-Rigid	Anesthesiology	Class 1	868.5530	2005-12-13
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2011-04-11
EQL	Laryngostroboscope	Ear, Nose, Throat	Class 1	874.4750	2011-03-31
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-10-24
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2016-06-10
KNY	Accessories, Catheter, G-U	Gastroenterology, Urology	Class 2	876.5130	2007-11-20
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2007-12-03
FWF	Camera, Television, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	1999-08-10
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2007-10-19
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2017-05-24
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2007-11-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-20
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2007-11-21
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2017-03-06
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2017-03-06
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2007-11-21
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2007-11-20
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2007-11-20
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2009-08-31
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2007-11-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-06-20
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2013-12-26
FDC	Resectoscope, Working Element	Gastroenterology, Urology	Class 2	876.1500	2007-11-21
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2007-11-21
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-11-20
NVT	Tubing And Tubing/Filter Fits	Obstetrics/Gynecology	Class 1	884.1700	2006-09-07
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2016-02-28
GBA	Catheter, Balloon Type	General, Plastic Surgery	Class 1	878.4200	2012-09-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-09
KCL	Blower, Powder, Ent	Ear, Nose, Throat	Class 1	874.5220	2009-03-18
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2007-11-14
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2007-10-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-19
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2021-04-26
FCS	Light, Catheter, Fiberoptic, Glass, Ureteral	Gastroenterology, Urology	Class 2	876.4020	2017-04-17
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-11-20
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2016-06-24
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2007-11-21
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2007-11-20
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2006-09-07
OSV	Insufflator, Endoscopic Vessel Harvesting	Obstetrics/Gynecology	Class 2	884.1730	2025-09-29
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2025-09-29
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2020-02-26
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-14
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-10-18
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-10-18
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2007-11-20
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2007-11-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-14
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2007-11-20
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2017-06-02
FBO	Cystourethroscope	Gastroenterology, Urology	Class 2	876.1500	2024-05-15
FDC	Resectoscope, Working Element	Gastroenterology, Urology	Class 2	876.1500	2024-05-15
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2024-05-15
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2024-05-15
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2024-05-15
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2007-11-19
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	1999-08-10
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2007-11-06
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-20
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-11-14
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-08-21
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2014-01-03
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2007-11-20
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-11-19
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-10-24
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2007-11-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-14
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2015-04-15
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-11-20
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2017-03-06
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2017-03-06
OSV	Insufflator, Endoscopic Vessel Harvesting	Obstetrics/Gynecology	Class 2	884.1730	2017-03-06
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2007-11-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-20
OCV	Endoscope Holder	Gastroenterology, Urology	Class 2	876.1500	2007-11-14
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2007-11-16
FBO	Cystourethroscope	Gastroenterology, Urology	Class 2	876.1500	2007-11-19
FGC	Urethroscope	Gastroenterology, Urology	Class 2	876.1500	2007-11-19
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2007-11-19
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2007-11-19
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2011-08-01
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2007-10-24
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2007-10-24
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2007-10-24
JYK	Holder, Ear Speculum	General, Plastic Surgery	Class 1	878.1800	2008-07-21
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2011-12-02
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2007-10-24
EPT	Microscope, Surgical	General, Plastic Surgery	Class 1	878.4700	2011-04-15
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2016-02-18
GCT	Light Source, Endoscope, Xenon Arc	Gastroenterology, Urology	Class 2	876.1500	2016-02-28
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2026-06-17
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2017-03-06
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-20
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2007-12-03
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2008-10-09
ODA	Endoscopic Central Control Unit	Gastroenterology, Urology	Class 2	876.1500	2007-10-19
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2007-11-20
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2023-05-12
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2006-08-15
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2007-06-20
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2022-11-09
ODA	Endoscopic Central Control Unit	Gastroenterology, Urology	Class 2	876.1500	2009-08-11
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2007-11-20
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2007-11-21
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2015-11-25
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2015-11-25
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-11-25
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2006-08-15
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2007-11-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-20
FEO	Lithotriptor, Ultrasonic	Gastroenterology, Urology	Class 2	876.4480	2007-11-14
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-09-09
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2006-09-07
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2007-11-20
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2007-11-20
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2007-11-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-10-24
JOS	Electrode, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2007-11-20
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-11-20
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2007-11-20
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2007-11-20
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-11-08
EWY	Mediastinoscope, Surgical	Ear, Nose, Throat	Class 2	874.4720	2007-11-20
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2007-11-08
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-20
FGA	Kit, Nephroscope	Gastroenterology, Urology	Class 2	876.1500	2007-11-19
HPP	Headlamp, Operating, Battery-Operated	Ophthalmic	Class 1	886.4335	2014-07-17
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-11-20
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2007-11-20
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-11-20
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	1999-08-10

Official Correspondent

No official correspondent registered.

US Agent Details

Anja Fair Business: KARL STORZ ENDOSCOPY-AMERICA, INC. Email: anja.fair@karlstorz.com Phone: (346) 8168200

Related Public Records

Same Entity

KARL STORZ SE & CO KG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3032429484	KARL STORZ Endovision, Inc.	Franklin, MA, US
3004644065	KARL STORZ VIDEO ENDOSCOPY ESTONIA OUE	Laagri Harjumaa, EE
3006546082	KARL STORZ SE & CO. KG	TUTTLINGEN Baden-Wurttemberg, DE
3014342096	KARL STORZ SE & CO KG	TUTTLINGEN Baden-Wurttemberg, DE
2020550	KARL STORZ ENDOSCOPY-AMERICA, INC.	Auburn, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K905383	Micro Surgical Instruments Corp.	2710-000 OSCILLATING SAW, GENERAL ASSEMBLY	1991-06-18
K913369	Micro Surgical Instruments Corp.	MICRO-AIRE MODEL 2060	1991-11-01
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

Similar Registrations

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9610617	KARL STORZ SE & CO. KG	TUTTLINGEN Baden-Wurttemberg, DE
3018094310	Medtronic Engineering and Innovation Center (MEIC)	Hyderabad Telangana, IN
3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010707607. Last updated year: 2026. Please use registration number 3010707607 when referencing this establishment in official correspondence.