KARL STORZ ENDOVISION, INC.

FDA Device Registration & Listing · CHARLTON, MA, US · Registration 1221826

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
1221826
FEI Number
1221826
Entity Name
KARL STORZ ENDOVISION, INC.
City/State/Country
CHARLTON, MA, US
Establishment Address
91 Carpenter Hill Rd, CHARLTON, MA 01507, US
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

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 Electronic LAPAROFLATOR 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FBN Choledochoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2007-11-14
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 1999-08-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2007-11-20
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2007-11-20
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2019-01-30
HRX Arthroscope Orthopedic Class 2 888.1100 2007-10-19
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-09-09
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2007-11-20
GWG Endoscope, Neurological Neurology Class 2 882.1480 2016-09-21
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2007-11-13
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2007-11-13
LYK Angioscope Gastroenterology, Urology Class 2 876.1500 2007-10-24
FBO Cystourethroscope Gastroenterology, Urology Class 2 876.1500 2025-08-04
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2007-11-08
FBN Choledochoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2007-11-19
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2007-11-20
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2007-11-14
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2007-11-12
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2007-11-14
FCW Light Source, Fiberoptic, Routine Gastroenterology, Urology Class 2 876.1500 2015-04-15
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2007-10-18
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2007-11-21
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2007-11-19
GWG Endoscope, Neurological Neurology Class 2 882.1480 2007-11-14
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2007-11-14
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2007-12-03
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2013-01-17
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2020-01-28
FBO Cystourethroscope Gastroenterology, Urology Class 2 876.1500 2020-01-28
HRX Arthroscope Orthopedic Class 2 888.1100 2007-11-20
GCT Light Source, Endoscope, Xenon Arc Gastroenterology, Urology Class 2 876.1500 2007-11-14
FCW Light Source, Fiberoptic, Routine Gastroenterology, Urology Class 2 876.1500 2007-11-14
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2007-11-14
EOX Esophagoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4710 2007-10-18
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2014-11-05
FBN Choledochoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2014-11-05
GCT Light Source, Endoscope, Xenon Arc Gastroenterology, Urology Class 2 876.1500 2016-02-28
FBO Cystourethroscope Gastroenterology, Urology Class 2 876.1500 2014-01-03
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2007-11-20
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2007-11-14
OAY Light Source System, Diagnostic Endoscopic Unknown Class 3 N/A 2010-09-16
GCT Light Source, Endoscope, Xenon Arc Gastroenterology, Urology Class 2 876.1500 2007-11-20
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2007-11-09
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2007-11-14
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2019-04-09
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 1999-08-10
MQW Transilluminator, Fiber Optic Ear, Nose, Throat Class 1 874.4350 2007-11-21
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2020-08-11
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2007-11-20
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2014-11-17
FBO Cystourethroscope Gastroenterology, Urology Class 2 876.1500 2007-06-20
GCT Light Source, Endoscope, Xenon Arc Gastroenterology, Urology Class 2 876.1500 2007-03-20
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2007-03-20
FWF Camera, Television, Endoscopic, Without Audio General, Plastic Surgery Class 1 878.4160 2007-03-20
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-07-15
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
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2007-11-21
FBN Choledochoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2007-11-08
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2021-09-21
FBO Cystourethroscope Gastroenterology, Urology Class 2 876.1500 2021-09-21
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2007-11-14
FBO Cystourethroscope Gastroenterology, Urology Class 2 876.1500 2009-03-24
FBN Choledochoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2007-11-09
FBO Cystourethroscope Gastroenterology, Urology Class 2 876.1500 2024-09-09
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-09-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K914997 Conmedcorp ASP-IRRATOR 1992-01-07
K153773 Olympus Medical Systems Corp. Disposal Lens Cleaning Sheath 2016-11-22
K940141 Micro-Medical Devices, Inc. LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH 1994-05-19
K933812 Advanced Surgical, Inc. ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES 1993-12-13
K254228 Karl Storz SE & CO. KG KARL STORZ Trocars with Valve Seals 2026-05-11

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0144-2024 Covidien 1
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024 Covidien 1
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024 Covidien 1
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
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.

Similar Registrations

Registration Number Establishment Name Location
3013992977 OTU Medical Inc Union City, CA, US
3022106566 SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD Shanghai, CN
2020550 KARL STORZ ENDOSCOPY-AMERICA, INC. Auburn, MA, US
9610617 KARL STORZ SE & CO. KG TUTTLINGEN Baden-Wurttemberg, DE
3002808148 SHIRAKAWA OLYMPUS CO., LTD. NISHISHIRAKAWA-GUN Fukushima, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1221826. Last updated year: 2026. Please use registration number 1221826 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.