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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

CountryMakers
United States7
Germany7
Japan5
China4
Costa Rica2
Vietnam1
South Korea1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer5March 6, 2026000api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center KaiseiAshigarakami-Gun Kanagawa, JapanComplaint file establishment, Specification developer4February 4, 2022000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Sano OfficeSano City Tochigi, JapanManufacturer4February 4, 2022000api.fda.gov
AOMORI OLYMPUS CO., LTD. Kuroishi SiteKUROISHI-SHI Aomori, JapanManufacturer3March 6, 2026000api.fda.gov
Horizons Intl. Corp.Heredia, Costa RicaContract manufacturer, Manufacturer, Repackager or relabeler2October 25, 2002000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer2March 15, 2021000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.NAN JING Jiangsu, ChinaManufacturer2March 15, 2021000api.fda.gov
Olympus Vietnam Co. Ltd.Dong Nai City, VietnamManufacturer2October 7, 2025000api.fda.gov
Avanos Medical, Inc.Alpharetta, GA, United StatesSpecification developer1January 28, 1994000api.fda.gov
Beijing ZKSK Technology Co., Ltd.beijing, ChinaManufacturer1December 14, 2023000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer1October 5, 2010000api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer1October 5, 2010000api.fda.gov
Conmed CorporationUtica, NY, United StatesManufacturer1March 19, 1991000api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer1March 19, 1991000api.fda.gov
FinemedixDaegu Gwangyeogsi, South KoreaManufacturer1May 21, 2025000api.fda.gov
Hangzhou AGS MedTech Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer, Repackager or relabeler1October 5, 2021000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer1March 28, 1995000api.fda.gov
Olympus Winter & Ibe GMBHHamburg, GermanyComplaint file establishment, Manufacturer, Specification developer1December 24, 1998000api.fda.gov
Ovesco Endoscopy AGTuebingen Baden-Wurttemberg, GermanyManufacturer, Specification developer1November 19, 2014000api.fda.gov
TeleMed SystemsNorthborough, MA, United StatesSpecification developer1December 22, 1999000api.fda.gov
Wilson-Cook Medical Inc.Winston Salem, NC, United StatesComplaint file establishment, Manufacturer1March 21, 2018000api.fda.gov
Bowa-Electronic GMBHGOMARINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Endo-Therapeutics, Inc.Clearwater, FL, United StatesContract manufacturer0000api.fda.gov
HOYA Corporation PENTAX Lifecare DivisionAkishima-shi Tokyo, JapanComplaint file establishment, Specification developer0000api.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

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.