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Data / Medical devices / Snare, Flexible

Snare, Flexible (FDI): 42 FDA-registered makers in 11 countries

42 establishments in 11 countries are registered with the FDA to make Snare, Flexible (product code FDI, Class 2, 21 CFR 876.4300). 28 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 63 510(k) clearances under this code, the latest on February 21, 2026, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
FDI
Device class
2
Regulation
876.4300
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States13
Germany8
China7
Japan3
Thailand3
Costa Rica2
South Korea2
Ireland1
Vietnam1
Mexico1
Czechia1

Makers of Snare, Flexible

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
United States Endoscopy Group, Inc.Mentor, OH, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler9October 7, 2021010api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer7October 8, 2020030api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer7October 8, 2020000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer7October 8, 2020000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer6October 8, 2020000api.fda.gov
Horizons Intl. Corp.Heredia, Costa RicaContract manufacturer, Manufacturer, Repackager or relabeler3December 23, 2008000api.fda.gov
AOMORI OLYMPUS CO., LTD. Kuroishi SiteKUROISHI-SHI Aomori, JapanManufacturer2December 7, 2017000api.fda.gov
Hangzhou AGS MedTech Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer, Repackager or relabeler2March 3, 2023000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer2February 21, 2026000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.NAN JING Jiangsu, ChinaManufacturer2February 21, 2026000api.fda.gov
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer2December 7, 2017000api.fda.gov
Olympus Vietnam Co. Ltd.Dong Nai City, VietnamManufacturer2December 7, 2017000api.fda.gov
Wilson-Cook Medical Inc.Winston Salem, NC, United StatesComplaint file establishment, Manufacturer2July 18, 2019010api.fda.gov
Ags Medtech (thailand) Co., Ltd.Pluak Daeng District Rayong, ThailandManufacturer, Repackager or relabeler1March 3, 2023000api.fda.gov
Avanos Medical, Inc.Alpharetta, GA, United StatesSpecification developer1October 13, 1992000api.fda.gov
Beijing ZKSK Technology Co., Ltd.beijing, ChinaManufacturer1June 6, 2022000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer1July 21, 2014000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer1June 7, 1993000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer1June 7, 1993000api.fda.gov
FinemedixDaegu Gwangyeogsi, South KoreaManufacturer1March 6, 2019000api.fda.gov
Incore Co., Ltd.Daegu, South KoreaManufacturer1November 21, 2022000api.fda.gov
Jiangsu Vedkang Medical Science and Technology Co.,Ltd.Changzhou Jiangsu, ChinaManufacturer1September 22, 2022000api.fda.gov
Medi-Globe GMBHAchenmuhle, Germany Bavaria, GermanyManufacturer1May 26, 1995000api.fda.gov
Micro-Tech Medical Technology (Thailand) Co., Ltd.Bang Lamung District Chon Buri, ThailandManufacturer1July 30, 2015000api.fda.gov
Ovesco Endoscopy AGTuebingen Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Specification developer1November 18, 2014000api.fda.gov
TeleMed SystemsNorthborough, MA, United StatesSpecification developer1June 18, 1990000api.fda.gov
Yangzhou Fartley Medical Instrument Technology Co., LtdYangzhou Jiangsu, ChinaContract manufacturer, Manufacturer1June 27, 2022000api.fda.gov
Zhejiang Chuangxiang Medical Technology Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer1March 7, 2018000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer for export0000api.fda.gov
Asahi Intecc (thailand) Co., Ltd.Amphur Muang Pathumthani Pathum Thani, ThailandContract manufacturer0000api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer0000api.fda.gov
Consolidated Medical Equipment CompanyChihuahua, MexicoContract manufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Eurofins STERIPAC GMBHCalw-Altburg Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
HOYA Corporation PENTAX Lifecare DivisionAkishima-shi Tokyo, JapanComplaint file establishment, Specification developer0000api.fda.gov
Isomedix Operations Inc.Spartanburg, SC, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Isomedix Operations Inc.S Plainfield, NJ, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification 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
Medi-Globe SroHRANICE Olomouc, CzechiaContract manufacturer0000api.fda.gov

Updated February 21, 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.