STORZ ENDOSKOP PRODUKTIONS GMBH

FDA Device Registration & Listing · SCHAFFHAUSEN, CH · Registration 9614434

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9614434
FEI Number
3002808273
Entity Name
STORZ ENDOSKOP PRODUKTIONS GMBH
City/State/Country
SCHAFFHAUSEN, CH
Establishment Address
SCHNECKENACKERSTRASSE 1, SCHAFFHAUSEN CH-8200, CH
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 HOPKINS Telescopes SCB Media Control ARTHROPUMP Plus CALCUSON 26025UC HAMOU Elctrnc HYSTEROFLATOR HAMOU ENDOMAT Disposable Tubing Set URETERO-RENOSCOPES/URETEROSCOPE HYSTEROSCOPIC INSU S-Pilot 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 KARL STORZ ICG Imaging System 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 KARL STORZ ICG Imaging System VACUSAFE TUBING SETS VOICE1 SCB R-UI Speech Control App CLEARVISION Lens Irrigation System KSEA CLEARVISION LE KARL STORZ ICG Imaging System LED light source Telepack + Laproscope

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 1999-08-10
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-08-21
FGA Kit, Nephroscope Gastroenterology, Urology Class 2 876.1500 2007-11-19
HRX Arthroscope Orthopedic Class 2 888.1100 1999-08-10
HRX Arthroscope Orthopedic Class 2 888.1100 2010-12-20
ODA Endoscopic Central Control Unit Gastroenterology, Urology Class 2 876.1500 2007-10-19
EOX Esophagoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4710 2020-01-28
ODA Endoscopic Central Control Unit Gastroenterology, Urology Class 2 876.1500 2007-11-30
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2007-12-03
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
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2016-06-24
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
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2007-11-21
NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic Obstetrics/Gynecology Class 1 884.1730 2006-09-07
FTA Light, Surgical, Accessories General, Plastic Surgery Class 2 878.4580 2007-10-19
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2007-10-24
FCZ Tube, Smoke Removal, Endoscopic Gastroenterology, Urology Class 1 876.1500 2015-06-23
HRX Arthroscope Orthopedic Class 2 888.1100 2007-11-21
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
HRX Arthroscope Orthopedic Class 2 888.1100 2006-09-07
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-03-02
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
EQL Laryngostroboscope Ear, Nose, Throat Class 1 874.4750 2011-03-31
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-04-06
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2007-10-24
FTA Light, Surgical, Accessories General, Plastic Surgery Class 2 878.4580 2007-10-24
HRX Arthroscope Orthopedic Class 2 888.1100 2007-11-06
FEO Lithotriptor, Ultrasonic Gastroenterology, Urology Class 2 876.4480 2007-11-09
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 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
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2007-11-16
NVT Tubing And Tubing/Filter Fits Obstetrics/Gynecology Class 1 884.1700 2006-09-07
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2016-06-10
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2006-08-15
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2016-02-18
GWG Endoscope, Neurological Neurology Class 2 882.1480 2023-12-01
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2023-12-01
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2023-12-01
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
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Gastroenterology, Urology Class 2 876.1500 2026-06-17
HRX Arthroscope Orthopedic Class 2 888.1100 2007-11-19
FEO Lithotriptor, Ultrasonic Gastroenterology, Urology Class 2 876.4480 2007-11-14
BTA Pump, Portable, Aspiration (Manual Or Powered) General, Plastic Surgery Class 2 878.4780 2020-08-03
HRX Arthroscope Orthopedic Class 2 888.1100 2020-08-03
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2020-08-03
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2020-08-03
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2020-08-03
GWG Endoscope, Neurological Neurology Class 2 882.1480 2020-08-03
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2020-08-03
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2007-12-03
GCT Light Source, Endoscope, Xenon Arc Gastroenterology, Urology Class 2 876.1500 2007-10-22
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2007-10-22
GWG Endoscope, Neurological Neurology Class 2 882.1480 2020-08-19
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2020-08-19
ODA Endoscopic Central Control Unit Gastroenterology, Urology Class 2 876.1500 2008-08-21
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2007-11-08
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2022-01-20
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2007-10-24
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2006-08-15
ODA Endoscopic Central Control Unit Gastroenterology, Urology Class 2 876.1500 2012-06-20
GWG Endoscope, Neurological Neurology Class 2 882.1480 2024-01-02
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2024-01-02
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2020-03-12
ODA Endoscopic Central Control Unit Gastroenterology, Urology Class 2 876.1500 2009-08-11
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2006-08-15
GWG Endoscope, Neurological Neurology Class 2 882.1480 2022-06-29
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2022-06-29
NTN Led Light Source Gastroenterology, Urology Class 2 876.1500 2016-02-28
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2022-07-08
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2007-11-14

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
K932506 Rudolf Riester GmbH & Co. KG RI-SCOPE (S) 1993-10-08
K081051 Spine View, Inc. SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 2008-08-07
K820777 The Anspach Effort, Inc. MINI-MICRO ARTHROSCOPIC SCAPEL 1982-05-12
K915458 Psi Medical Products, Inc. URETEROSCOPE 1992-01-30
K260108 Stryker Endoscopy L12 LED Light Source with AIM 2026-02-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.
Z-0010-2023 Hobbs Medical, Inc. 2
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023 Hobbs Medical, Inc. 2
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191
Z-0035-2007 Haemonetics Corporation 2
SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614434. Last updated year: 2026. Please use registration number 9614434 when referencing this establishment in official correspondence.
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