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Data / Medical devices / Endoscope, Neurological

Endoscope, Neurological (GWG): 51 FDA-registered makers in 11 countries

51 establishments in 11 countries are registered with the FDA to make Endoscope, Neurological (product code GWG, Class 2, 21 CFR 882.1480). 21 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 95 510(k) clearances under this code, the latest on October 16, 2026, and lists 15 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
GWG
Device class
2
Regulation
882.1480
Medical specialty
Neurology

Makers by country

CountryMakers
United States23
Germany15
Taiwan3
Japan2
Switzerland2
France1
South Korea1
Singapore1
Estonia1
Mexico1
Ireland1

Makers of Endoscope, Neurological

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Karl Storz Endoscopy-America, Inc.Auburn, MA, United StatesContract manufacturer, Repackager or relabeler12April 17, 2018000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer11October 14, 2026000api.fda.gov
Medtronic NeurosurgeryFort Worth, TX, United StatesSpecification developer7April 20, 2001030api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer5July 11, 2006000api.fda.gov
Clarus Medical, LLC.Minneapolis, MN, United StatesManufacturer4November 21, 2023000api.fda.gov
Carl Zeiss Meditec AG (oberkochen)OBERKOCHEN Baden-Wurttemberg, GermanyManufacturer3September 21, 2023000api.fda.gov
Penumbra, Inc.Alameda, CA, United StatesManufacturer3August 14, 2017000api.fda.gov
Penumbra Inc.Roseville, CA, United StatesManufacturer3August 14, 2017000api.fda.gov
Penumbra Inc.Salt Lake City, UT, United StatesManufacturer3August 14, 2017000api.fda.gov
Penumbra Inc.Livermore, CA, United StatesManufacturer3August 14, 2017000api.fda.gov
Rebound Therapeutics, CorporationIrvine, CA, United StatesManufacturer3April 9, 2025000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer3November 23, 2005000api.fda.gov
Clearmind BiomedicalTaipei City, TaiwanExporter to the US, Specification developer2October 13, 2023000api.fda.gov
Hjy Smart Medical Device Co., Ltd.Taipei City, TaiwanSpecification developer2May 21, 2025000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesComplaint file establishment, Manufacturer, Specification developer2June 4, 2026000api.fda.gov
ClearPoint Neuro Inc.Carlsbad, CA, United StatesManufacturer1November 20, 2018000api.fda.gov
Geomed Medizin-Technik GMBH & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer1November 23, 2005010api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer1January 27, 1999000api.fda.gov
Mauna Kea TechnologiesPARIS Ile-de-France, FranceManufacturer1May 22, 2018000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer1May 8, 2026000api.fda.gov
Vpix Medical, Inc.Jung-gu Daejeon, South KoreaManufacturer1August 21, 2024000api.fda.gov
Bacher Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
BENTEC Endoscopy GmbHRietheim-Weilheim Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Fibertech Co., Ltd.Sakura-shi Chiba, JapanContract manufacturer0000api.fda.gov
Fong's Engineering & Manufacturing Private LimitedSingapore Central Singapore, SingaporeContract manufacturer0000api.fda.gov
Gebruder Renggli, AGSchaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Henke-Sass Wolf, GMBH.TUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
HGR Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Jr-Medizintechnik GMBH & Co KGLeibertingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Endovision, Inc.Charlton, MA, United StatesContract manufacturer0000api.fda.gov
Karl Storz Imaging, Inc.Goleta, CA, United StatesContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Video Endoscopy Estonia OueLaagri Harjumaa, EstoniaContract manufacturer0000api.fda.gov
Kimball Solutions Jasper, Inc.Jasper, IN, United StatesContract manufacturer0000api.fda.gov
Linemaster Switch Corp.Woodstock, CT, United StatesContract manufacturer0000api.fda.gov
Martech Medical Products S. De RL. De CV.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Mitaka Kohki Co., Ltd.MITAKA SHI Tokyo, JapanContract manufacturer, Manufacturer0000api.fda.gov
New Deantronics Taiwan Ltd.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
Richard Wolf Medical Instruments Corp.Vernon Hills, IL, United StatesContract manufacturer0000api.fda.gov
Rominger Medizintechnik GMBHSEITINGEN-OBERFLACHT Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Scientific Molding Corporation, Ltd. Dba SMC Ltd.Santa Rosa, CA, United StatesContract manufacturer0000api.fda.gov
Storz Endoskop Produktions GMBHSchaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesContract manufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Manufacturing Ltd.SWORDS Dublin(County), IrelandManufacturer0000api.fda.gov
Strub Medical GmbH & Co. KGNEUHAUSEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov

Updated October 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.