FDA Registration
Active
🇺🇸 United States
KARL STORZ ENDOVISION, INC.
Reg #: 1221826
·
FEI: 1221826
·
Expires 2026
Products
31
Proprietary Names
81
Establishment Types
2
Classifications
31
Registration Details
- Registration Name
- KARL STORZ ENDOVISION, INC.
- Registration Number
- 1221826
- FEI Number
- 1221826
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 91 Carpenter Hill Rd
- City
- CHARLTON
- State
- MA
- ZIP
- 01507
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243550
Owner / Operator
- Firm Name
- KARL STORZ SE & CO KG
- Operator Number
- 8010119
- Address
- Dr.-Karl-Storz-Strasse 34,
- City
- TUTTLINGEN
- State
- Baden-Wurttemberg
- Postal Code
- 78532
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Choledochoscope And Accessories, Flexible/Rigid | FBN | Class 2 | Gastroenterology, Urology | No | 2007-11-14 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 1999-08-10 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2007-11-20 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2007-11-20 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2007-10-19 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2024-09-09 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2007-11-20 |
| Endoscope, Neurological | GWG | Class 2 | Neurology | No | 2016-09-21 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2007-11-13 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2007-11-13 |
| Angioscope | LYK | Class 2 | Gastroenterology, Urology | No | 2007-10-24 |
| Cystourethroscope | FBO | Class 2 | Gastroenterology, Urology | No | 2025-08-04 |
| Light Source, Fiberoptic, Routine | FCW | Class 2 | Gastroenterology, Urology | No | 2015-04-15 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2007-11-19 |
| Light Source, Endoscope, Xenon Arc | GCT | Class 2 | Gastroenterology, Urology | No | 2007-11-14 |
| Esophagoscope (Flexible Or Rigid) | EOX | Class 2 | Ear, Nose, Throat | No | 2007-10-18 |
| Light Source System, Diagnostic Endoscopic | OAY | Class 3 | Unknown | No | 2010-09-16 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2007-11-09 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2007-11-14 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 1999-08-10 |
| Transilluminator, Fiber Optic | MQW | Class 1 | Ear, Nose, Throat | No | 2007-11-21 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2007-03-20 |
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 2007-03-20 |
| Image, Illumination, Fiberoptic, For Endoscope | FFS | Class 2 | Gastroenterology, Urology | No | 2007-11-21 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2007-11-14 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2007-03-20 |
| Sigmoidoscope And Accessories, Flexible/Rigid | FAM | Class 2 | Gastroenterology, Urology | No | 2007-03-20 |
| Kit, Nephroscope | FGA | Class 2 | Gastroenterology, Urology | No | 2007-10-24 |
| Light Source, Photographic, Fiberoptic | FCR | Class 2 | Gastroenterology, Urology | No | 2007-11-14 |
| Laryngoscope, Non-Rigid | CAL | Class 1 | Anesthesiology | No | 2005-12-13 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2007-11-08 |
Proprietary Names
11274AC Flex. CHOLEDOCHOSCOPE
KARL STORZ LARYNGOSCOPE
Fluid Light Cables
Electronic LAPAROFLATOR
Powershaver System S2
KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S
Flex. HYSTEROSCOPE
KARL STORZ Flexible Video-Neuro-Endoscope System
Nasopharyngoscope
Fiberscope
KARL STORZ Cysto-Urethro-Fiberscope
MVM 3.3 MM MICROENDOSCOPE
Flexible Choledochoscope
MVM 7.5 French Flex. HYSTEROSCOPE
N20 ENDOFLATOR
Endoscope
Power LED 175 Light Fountain
Light Fountain 50 Watts
Miniature Endoscope
Elec Endoflator, Model 264305 20
Series 11274 Flexible Fiberscope
Neuro FIBERSCOPE
Series 11274 Flex. URETEROSCOPE
Flexible Hysteroscope, 10.5 Fr
CMOS Video Rhino Laryngoscope
HD View
CO2 ARTHROFLATOR
Xenon Light Source (175W) 201320-20
Electronic LAPAROFLATOR (20 LPM)
Trans-Nasal Esophagoscopes
Flexible Video-Uretero-Choledochoscope-System
Xenon Nova Light Source
Flexible CMOS Video-Cysto Urethroscope
RHINO-PHARYNGO-LARYNGO FIBERSCOPE
MVM 7.5 French Flex. URETEROSCOPE
FLEX-X2
Light source system, diagnostic endoscopic
XENON NOPPVA
MVM 3.3 MM Micro-Endoscope
26025UC HAMOU Elctrnc HYSTEROFLATOR
CMOS Video-Rhino-Laryngoscope System
KARL STORZ OTOSCOPE
OTOSCOPE
Twin Transilluminator
Flexible HD Video Rhino-Laryngoscope System
Fiber Optic Light Cables
Ureteroscope and accessories, flexible/rigid
Flexible Video-urethro-cystoscope
KARL STORZ FLEXIBLE VIDEO-
KARL STORZ VIDEO GASTROSCOPES
Video Gastroscopes
KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
HD-View
Intubation Fiberscope
Flexible CHOLEDOCHOSCOPE
Flexible HD Cysto-Urethroscope System
495N Series Fibr Optic Light Cables
Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories
7.5 Fr. Flexible CHOLEDOSCHOSCOPE
KARL STORZ Ped. Cysto-Urethro-Fiberscope
Electronic LAPAROFLATOR (10 LPM)
KARL STORZ Pediatric Cysto-Urethro-Fiberscope
Rhino-Laryngo-Bronco Fiberscope
300W Light Source, Non-flash
CO2 Endoflator
Cystoscope 78FAJ, Fiberoptic 78GDB
Model 27224P Continuous Flow Pump
Video Flexible ENT Endoscope System
Neuro-Fiberscope
Slim Nasopharyngolaryngoscope
KARL STORZ VIDEO LOWER
Video Lower G.I. Endoscope System
KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE
THERMOFLATOR, Model 26 4320 20
EPIDUROSCOPE
Vascular Fiberscopes
11274AB Flex Pediatric BRONCHOSCOPE
Flexible Video Cysto-Urethroscope
Xenon Light Source/Flash
DCI VIDEO LARYNGOSCOPE
Monopolar Coagulating Electrodes
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device