KARL STORZ IMAGING, INC.

FDA Device Registration & Listing · Goleta, CA, US · Registration 2027009

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
2027009
FEI Number
2027009
Entity Name
KARL STORZ IMAGING, INC.
City/State/Country
Goleta, CA, US
Establishment Address
1 S Los Carneros Rd, Goleta, CA 93117, 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

C-Cam TIPCAM 1S 3D System KARL STORZ ICG Imaging System GI CCU KARL STORZ Endoscopic ICG Imaging System Camera Flexible Video-Uretero-Renoscope Flex-XC Camera H1 Camera Head Laproscopy Insstruments KARL STORZ ICG Imaging System LAPAROCAM KARL STORZ ICG System NEO NEO IP Camera, ophthalmic, ac-powered 12G-SDI CABLE, Camera KARL STORZ Image1 S Camera Control Unit KARL STORZ ICG Imaging System KARL STORZ ICG Imaging System Endoscope Accessories Tape and bandage, adhesive, adjustable closing mechanism, OTC use Ureteroscope and accessories, flexible/rigid KARL STORZ ICG Imaging System ENDOSCOPE ACCESSORIES

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2020-08-12
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2015-11-25
GWG Endoscope, Neurological Neurology Class 2 882.1480 2017-03-17
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2017-03-06
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2013-04-25
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2016-06-24
FTS Camera, Cine, Endoscopic, With Audio General, Plastic Surgery Class 1 878.4160 2013-04-11
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2013-12-26
FWF Camera, Television, Endoscopic, Without Audio General, Plastic Surgery Class 1 878.4160 2007-11-14
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-11-30
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2007-11-12
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2022-01-04
GWG Endoscope, Neurological Neurology Class 2 882.1480 2022-01-04
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2007-10-24
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2016-03-28
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2017-07-11
LMD System, Digital Image Communications, Radiological Radiology Class 1 892.2020 2008-11-25
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2007-11-21
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2007-11-21
FEM Accessories, Photographic, For Endoscope (Exclude Light Sources) Gastroenterology, Urology Class 1 876.1500 2019-03-15
FWF Camera, Television, Endoscopic, Without Audio General, Plastic Surgery Class 1 878.4160 2007-11-14
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
GWG Endoscope, Neurological Neurology Class 2 882.1480 2020-08-19
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2020-08-19
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2007-12-03
PYO Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use General Hospital Class 1 880.5240 2022-06-07
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2014-11-17
GWG Endoscope, Neurological Neurology Class 2 882.1480 2022-06-29
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2022-06-29
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2007-11-09

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-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.
Z-0009-2018 Optovue, Inc. 2
iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior. ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.

Similar Registrations

Registration Number Establishment Name Location
3016762717 Parametrik Holdings LLC Elmsford, NY, US
3005099803 BOSTON SCIENTIFIC CORPORATION Marlborough, MA, US
3006161756 FUJIFILM Healthcare Manufacturing Corporation Sano Office Sano City Tochigi, JP
3022106566 SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD Shanghai, CN
2936485 STRYKER ENDOSCOPY SAN JOSE, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2027009. Last updated year: 2026. Please use registration number 2027009 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.