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Data / Medical devices / Dislodger, Stone, Flexible

Dislodger, Stone, Flexible (FGO): 16 FDA-registered makers in 5 countries

16 establishments in 5 countries are registered with the FDA to make Dislodger, Stone, Flexible (product code FGO, Class 2, 21 CFR 876.4680). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on November 22, 2000, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
FGO
Device class
2
Regulation
876.4680
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States9
Germany4
China1
Monaco1
Mexico1

Makers of Dislodger, Stone, 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, Manufacturer1October 4, 1996010api.fda.gov
Ackermann Instrumente GMBHRIETHEIM, WEILHEIM Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer for export0000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesSpecification developer0000api.fda.gov
Epflex Feinwerktechnik GMBHDETTINGEN/ERMS Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Gyrus Acmi, Inc.Westborough, MA, United StatesSpecification developer0000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesManufacturer0000api.fda.gov
H.+H. Maslanka Chirurgische Instrumente GmbHTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Innovex Medical Co., Ltd.Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Nissha Medical Technologies (Ohio), Inc.Norwalk, OH, United StatesContract manufacturer0000api.fda.gov
Promepla S.A.MMONACO Monaco-Ville, MonacoContract manufacturer0000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesManufacturer0000api.fda.gov
Tekno Medical Optik-Chirurgie GMBHTUTTLINGEN-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Venusa de Mexico S. de R.L de C.VCIUDAD JUAREZ Chihuahua, MexicoContract manufacturer0000api.fda.gov

Updated November 22, 2000. 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.