FDA Registration
Active
🇨🇭 Switzerland
STORZ ENDOSKOP PRODUKTIONS GMBH
Reg #: 9614434
·
FEI: 3002808273
·
Expires 2026
Products
38
Proprietary Names
69
Establishment Types
2
Classifications
38
Registration Details
- Registration Name
- STORZ ENDOSKOP PRODUKTIONS GMBH
- Registration Number
- 9614434
- FEI Number
- 3002808273
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- SCHNECKENACKERSTRASSE 1
- City
- SCHAFFHAUSEN
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K243653
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
US Agent
- Business Name
- KARL STORZ ENDOSCOPY-AMERICA, INC.
- Contact Name
- Anja Fair
- Address
- 2151 E Grand Ave
- City
- El Segundo
- State
- CA
- ZIP
- 90245
- Country
- US
- [email protected]
- Phone
- 346 8168200
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 1999-08-10 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2025-08-21 |
| Kit, Nephroscope | FGA | Class 2 | Gastroenterology, Urology | No | 2007-11-19 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 1999-08-10 |
| Endoscopic Central Control Unit | ODA | Class 2 | Gastroenterology, Urology | No | 2007-10-19 |
| Esophagoscope (Flexible Or Rigid) | EOX | Class 2 | Ear, Nose, Throat | No | 2020-01-28 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2007-12-03 |
| Cystourethroscope | FBO | Class 2 | Gastroenterology, Urology | No | 2007-11-19 |
| Urethroscope | FGC | Class 2 | Gastroenterology, Urology | No | 2007-11-19 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2007-11-19 |
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2016-06-24 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2018-11-20 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2018-11-20 |
| Endoscope, Neurological | GWG | Class 2 | Neurology | No | 2018-11-20 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2018-11-20 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2018-11-20 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2006-09-07 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2007-10-19 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2007-10-24 |
| Tube, Smoke Removal, Endoscopic | FCZ | Class 1 | Gastroenterology, Urology | No | 2015-06-23 |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | FCX | Class 2 | Gastroenterology, Urology | No | 2017-03-06 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2017-03-06 |
| Insufflator, Endoscopic Vessel Harvesting | OSV | Class 2 | Obstetrics/Gynecology | No | 2017-03-06 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-03-02 |
| Telescope, Laryngeal-Bronchial | ENZ | Class 2 | Ear, Nose, Throat | No | 2007-11-20 |
| Laryngostroboscope | EQL | Class 1 | Ear, Nose, Throat | No | 2011-03-31 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2007-10-24 |
| Lithotriptor, Ultrasonic | FEO | Class 2 | Gastroenterology, Urology | No | 2007-11-09 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2007-11-14 |
| Tubing And Tubing/Filter Fits | NVT | Class 1 | Obstetrics/Gynecology | No | 2006-09-07 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2016-06-10 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2016-02-18 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ | Class 2 | Gastroenterology, Urology | No | 2026-06-17 |
| Light Source, Endoscope, Xenon Arc | GCT | Class 2 | Gastroenterology, Urology | No | 2007-10-22 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2020-03-12 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2016-02-28 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2007-10-18 |
| Lithotriptor, Electro-Hydraulic | FFK | Class 2 | Gastroenterology, Urology | No | 2007-11-12 |
Proprietary Names
KARL STORZ OTOSCOPE
OTOSCOPE
KARL STORZ HOPKINS Telescopes for Urology
Nephroscope, Adult & Pediatric
ARTHRO PUMP
Karl Storz Arthropump Power Irrigation/Suction Pump, Tubing
SCB/VALLEY LAB Force FX Interface
CMOS Endoscopes SSU
SCB Interface Control #20090120
MTP CLEARVISION Disp Tubing Set
HOPKINS I/II Autoclavable Telescope
KARL STORZ Endoscopic ICG Imaging System
Endomat Select (Model Number: UP210)
EQUIMAT, Model 203020 20
TUBING SET FOR LAPAROSCOPIC INSUFFL
TUBING
SCB/STERIS OR-Light Interface Box
Uterine Manipulator
Smoke Removal Tube
S-Pilot
Instr Set Percut Discect/Nucleotomy
ENDOFLATOR 40&50
MTP ARTHROUMP TUBING SET
HOPKINS Telescopes
ENT Rigid Telescopes
KARL STORZ PULSAR II
SCB Media Control
ARTHROPUMP Plus
CALCUSON
26025UC HAMOU Elctrnc HYSTEROFLATOR
HAMOU ENDOMAT Disposable Tubing Set
URETERO-RENOSCOPES/URETEROSCOPE
HYSTEROSCOPIC INSU
ENDOMAT LC PUMP
Unidrive SIII ENT
KARL STORZ Image1 S Camera Control Unit
KARL STORZ ICG Imaging System
UNIMAT Plus
Nasopharyngo/Broncho/Tracheoscopes
KARL STORZ Endoscopic Accessories for Urology
Arthroscopic Telescopes
Model 27086C Ultrasonic LITHOTRITE
Endomat Select
Endoscope Accessories
Medi Pack
SCB/CONMED ESU INTERFACE MODULE
HYDROMAT, Model 263110 20
SSU Flexible Video-Uretero-Renoscope
Hysteromat II
SCB-RUI (Realistic User Interface)
SCB/Covidien Force Triad Interface Module
VACUSAFE TUBING SETS
VOICE1 SCB R-UI Speech Control App
CLEARVISION Lens Irrigation System
KSEA CLEARVISION LE
LED light source
Telepack +
Laproscope
GAAB Rigid NEUROENDOSCOPES
Image 1 SPIES
Autocon II 400 Electrosurgical Gen
MTP Extraction Bags
CALCUSPLIT
THERMOFLATOR, Model 26 4320 20
Rigid Telescopes
KSEA CLEARVISION II, MODEL 40334120
EQUIMAT Model 203020 20
Powershaver System S2
KARL STORZ HOPKINS Telescopes
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device