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Data / Medical devices / Trocar, Gastro-Urology

Trocar, Gastro-Urology (FBQ): 25 FDA-registered makers in 7 countries

25 establishments in 7 countries are registered with the FDA to make Trocar, Gastro-Urology (product code FBQ, Class 2, 21 CFR 876.5090). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on August 9, 2001, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code
FBQ
Device class
2
Regulation
876.5090
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
Germany11
United States5
India3
Pakistan3
Dominican Republic1
China1
Brazil1

Makers of Trocar, Gastro-Urology

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
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer1December 23, 1993000api.fda.gov
CovidienNorth Haven, CT, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer1April 4, 1990000api.fda.gov
CovidienPonce, PR, United StatesContract manufacturer, Manufacturer1April 4, 1990000api.fda.gov
Covidien- Santo Domingo, Dominican RepublicManufacturer1April 4, 1990000api.fda.gov
Allwin Medical Devices Pvt. Ltd.Surat Gujarat, IndiaManufacturer0000api.fda.gov
Auxein medical Private limitedSonipat Haryana, IndiaManufacturer0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
BAK KOHLER Medical KGNEUHAUSEN OB ECK-Schwandorf Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Biorad Medisys Pvt. Ltd.Pune Maharashtra, IndiaManufacturer0000api.fda.gov
Busse Hospital DisposablesHauppauge, NY, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0010api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Hangzhou Endo Medical Instrument Co.,ltdhangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Heinrich Medizintechnik GMBHStuttgart Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
ITM Industria de Tecnologias Medicas LTDACANOAS Rio Grande do Sul, BrazilManufacturer0000api.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
Meister Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
SurgicraftsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Tontarra Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Trokamed GMBHGEISINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov

Updated August 9, 2001. 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.