Data / Medical devices / Forceps, Biopsy, Electric
Forceps, Biopsy, Electric (KGE): 27 FDA-registered makers in 7 countries
27 establishments in 7 countries are registered with the FDA to make Forceps, Biopsy, Electric (product code KGE, Class 2, 21 CFR 876.4300). 21 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 46 510(k) clearances under this code, the latest on March 6, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KGE
- Device class
- 2
- Regulation
- 876.4300
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Germany | 7 |
| Japan | 5 |
| China | 4 |
| Costa Rica | 2 |
| Vietnam | 1 |
| South Korea | 1 |
Makers of Forceps, Biopsy, Electric
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 |
|---|---|---|---|---|---|---|---|---|
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 5 | March 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Corporation Medical Systems Research & Development Center Kaisei | Ashigarakami-Gun Kanagawa, Japan | Complaint file establishment, Specification developer | 4 | February 4, 2022 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Sano Office | Sano City Tochigi, Japan | Manufacturer | 4 | February 4, 2022 | 0 | 0 | 0 | api.fda.gov |
| AOMORI OLYMPUS CO., LTD. Kuroishi Site | KUROISHI-SHI Aomori, Japan | Manufacturer | 3 | March 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Horizons Intl. Corp. | Heredia, Costa Rica | Contract manufacturer, Manufacturer, Repackager or relabeler | 2 | October 25, 2002 | 0 | 0 | 0 | api.fda.gov |
| Micro-Tech (Nanjing) Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 2 | March 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Micro-Tech (Nanjing) Co., Ltd. | NAN JING Jiangsu, China | Manufacturer | 2 | March 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Olympus Vietnam Co. Ltd. | Dong Nai City, Vietnam | Manufacturer | 2 | October 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| Avanos Medical, Inc. | Alpharetta, GA, United States | Specification developer | 1 | January 28, 1994 | 0 | 0 | 0 | api.fda.gov |
| Beijing ZKSK Technology Co., Ltd. | beijing, China | Manufacturer | 1 | December 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 1 | October 5, 2010 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | El Coyol Alajuela, Costa Rica | Manufacturer | 1 | October 5, 2010 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Utica, NY, United States | Manufacturer | 1 | March 19, 1991 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Westborough, MA, United States | Specification developer | 1 | March 19, 1991 | 0 | 0 | 0 | api.fda.gov |
| Finemedix | Daegu Gwangyeogsi, South Korea | Manufacturer | 1 | May 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer, Repackager or relabeler | 1 | October 5, 2021 | 0 | 0 | 0 | api.fda.gov |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 1 | March 28, 1995 | 0 | 0 | 0 | api.fda.gov |
| Olympus Winter & Ibe GMBH | Hamburg, Germany | Complaint file establishment, Manufacturer, Specification developer | 1 | December 24, 1998 | 0 | 0 | 0 | api.fda.gov |
| Ovesco Endoscopy AG | Tuebingen Baden-Wurttemberg, Germany | Manufacturer, Specification developer | 1 | November 19, 2014 | 0 | 0 | 0 | api.fda.gov |
| TeleMed Systems | Northborough, MA, United States | Specification developer | 1 | December 22, 1999 | 0 | 0 | 0 | api.fda.gov |
| Wilson-Cook Medical Inc. | Winston Salem, NC, United States | Complaint file establishment, Manufacturer | 1 | March 21, 2018 | 0 | 0 | 0 | api.fda.gov |
| Bowa-Electronic GMBH | GOMARINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endo-Therapeutics, Inc. | Clearwater, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HOYA Corporation PENTAX Lifecare Division | Akishima-shi Tokyo, Japan | Complaint file establishment, Specification developer | 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 |
Updated March 6, 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.