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
| Country | Makers |
|---|---|
| United States | 23 |
| Germany | 15 |
| Taiwan | 3 |
| Japan | 2 |
| Switzerland | 2 |
| France | 1 |
| South Korea | 1 |
| Singapore | 1 |
| Estonia | 1 |
| Mexico | 1 |
| Ireland | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Karl Storz Endoscopy-America, Inc. | Auburn, MA, United States | Contract manufacturer, Repackager or relabeler | 12 | April 17, 2018 | 0 | 0 | 0 | api.fda.gov |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 11 | October 14, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Neurosurgery | Fort Worth, TX, United States | Specification developer | 7 | April 20, 2001 | 0 | 3 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 5 | July 11, 2006 | 0 | 0 | 0 | api.fda.gov |
| Clarus Medical, LLC. | Minneapolis, MN, United States | Manufacturer | 4 | November 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Carl Zeiss Meditec AG (oberkochen) | OBERKOCHEN Baden-Wurttemberg, Germany | Manufacturer | 3 | September 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Penumbra, Inc. | Alameda, CA, United States | Manufacturer | 3 | August 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| Penumbra Inc. | Roseville, CA, United States | Manufacturer | 3 | August 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| Penumbra Inc. | Salt Lake City, UT, United States | Manufacturer | 3 | August 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| Penumbra Inc. | Livermore, CA, United States | Manufacturer | 3 | August 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| Rebound Therapeutics, Corporation | Irvine, CA, United States | Manufacturer | 3 | April 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 3 | November 23, 2005 | 0 | 0 | 0 | api.fda.gov |
| Clearmind Biomedical | Taipei City, Taiwan | Exporter to the US, Specification developer | 2 | October 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Hjy Smart Medical Device Co., Ltd. | Taipei City, Taiwan | Specification developer | 2 | May 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Stryker Endoscopy | San Jose, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | June 4, 2026 | 0 | 0 | 0 | api.fda.gov |
| ClearPoint Neuro Inc. | Carlsbad, CA, United States | Manufacturer | 1 | November 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Geomed Medizin-Technik GMBH & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | November 23, 2005 | 0 | 1 | 0 | api.fda.gov |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 1 | January 27, 1999 | 0 | 0 | 0 | api.fda.gov |
| Mauna Kea Technologies | PARIS Ile-de-France, France | Manufacturer | 1 | May 22, 2018 | 0 | 0 | 0 | api.fda.gov |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 1 | May 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Vpix Medical, Inc. | Jung-gu Daejeon, South Korea | Manufacturer | 1 | August 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Bacher Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BENTEC Endoscopy GmbH | Rietheim-Weilheim Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fibertech Co., Ltd. | Sakura-shi Chiba, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fong's Engineering & Manufacturing Private Limited | Singapore Central Singapore, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gebruder Renggli, AG | Schaffhausen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henke-Sass Wolf, GMBH. | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HGR Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jr-Medizintechnik GMBH & Co KG | Leibertingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Endovision, Inc. | Charlton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Imaging, Inc. | Goleta, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Video Endoscopy Estonia Oue | Laagri Harjumaa, Estonia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Solutions Jasper, Inc. | Jasper, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linemaster Switch Corp. | Woodstock, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Martech Medical Products S. De RL. De CV. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mitaka Kohki Co., Ltd. | MITAKA SHI Tokyo, Japan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Deantronics Taiwan Ltd. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olive Branch Distribution Center | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf Medical Instruments Corp. | Vernon Hills, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rominger Medizintechnik GMBH | SEITINGEN-OBERFLACHT Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Molding Corporation, Ltd. Dba SMC Ltd. | Santa Rosa, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Storz Endoskop Produktions GMBH | Schaffhausen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Puerto Rico, LLC. | Arroyo, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Manufacturing Ltd. | SWORDS Dublin(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Strub Medical GmbH & Co. KG | NEUHAUSEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.