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Data / Medical devices / Evacuator, Gastro-Urology

Evacuator, Gastro-Urology (KQT): 35 FDA-registered makers in 7 countries

35 establishments in 7 countries are registered with the FDA to make Evacuator, Gastro-Urology (product code KQT, Class 2, 21 CFR 876.4370). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on December 16, 1996, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
KQT
Device class
2
Regulation
876.4370
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States17
Germany6
China5
Switzerland2
India2
Mexico2
Ireland1

Makers of Evacuator, 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
E.M.S. Electro Medical Systems S.A.NYON Vaud, SwitzerlandComplaint file establishment, Remanufacturer, Specification developer1December 16, 1996000api.fda.gov
E.M.S. Electro Medical Systems S.A.NYON Vaud, SwitzerlandManufacturer1December 16, 1996000api.fda.gov
Electro Medical Systems, L.L.C.Southlake, TX, United StatesRemanufacturer, Repackager or relabeler1December 16, 1996000api.fda.gov
Northgate Technologies Inc.Elgin, IL, United StatesComplaint file establishment, Manufacturer1October 28, 1992010api.fda.gov
Aulea Medical, Inc.Pleasanton, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Allwin Medical Devices Pvt. Ltd.Surat Gujarat, IndiaManufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesSpecification developer0000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer0000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer0000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract sterilizer, Specification developer0000api.fda.gov
Conod Medical Shuyang Co., Ltd.Shuyang Jiangsu, ChinaContract manufacturer0000api.fda.gov
Conod Medical Co.,LimitedChangshu Jiangsu, ChinaContract manufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Endonest Medical Systems LLPPALGHAR Maharashtra, IndiaManufacturer0000api.fda.gov
Gri Medical Products, Inc.Cave Creek, AZ, United StatesManufacturer0000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Henke-Sass Wolf, GMBH.TUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Integra Biotechnical, SA de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Koscher & Wuertz GMBHSPAICHINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
National Advanced Endoscopy Devices, Inc.Canoga Park, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Nissha Medical Technologies (Ohio), Inc.Norwalk, OH, United StatesContract manufacturer0000api.fda.gov
PalliareGalway Galway(County), IrelandManufacturer0000api.fda.gov
Peter's Technology (suzhou) Co., Ltd.Suzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Productos Para El Cuidado De La SaludNOGALES Sonora, MexicoContract manufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Shenzhen Trious Medical Technology Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesManufacturer, Specification developer0000api.fda.gov
The Metrix CompanyDubuque, IA, United StatesContract manufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
United States Endoscopy Group, Inc.Mentor, OH, United StatesManufacturer0000api.fda.gov

Updated December 16, 1996. 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.