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Data / Medical devices / Tube, Smoke Removal, Endoscopic

Tube, Smoke Removal, Endoscopic (FCZ): 35 FDA-registered makers in 13 countries

35 establishments in 13 countries are registered with the FDA to make Tube, Smoke Removal, Endoscopic (product code FCZ, Class 1, 21 CFR 876.1500). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
FCZ
Device class
1
Regulation
876.1500
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States9
Germany6
China4
Taiwan3
United Kingdom3
Pakistan2
Mexico2
Canada1
India1
Ireland1
Tunisia1
Monaco1
Switzerland1

Makers of Tube, Smoke Removal, Endoscopic

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
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Aptyx - TrentonTRENTON Ontario, CanadaContract manufacturer0000api.fda.gov
Bioteque Corporation Yilan Science Park FactoryYilan City, TaiwanContract manufacturer, Contract sterilizer0000api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer0000api.fda.gov
Eltek Instruments (pvt.) Ltd.Sialkot Punjab, PakistanContract manufacturer0000api.fda.gov
Ethicon, Inc.CIUDAD JUAREZ Chihuahua, MexicoContract manufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
GVS Filter Technology UK LtdLancaster Lancashire, United KingdomManufacturer0000api.fda.gov
Heng Chuang Plastic & Metal Co., LtdDongguan Guangdong, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
JosNoe Medical IncNixa, MO, United StatesSpecification developer0000api.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. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Lexion Medical, LLC.Saint Paul, MN, United StatesManufacturer0000api.fda.gov
Meditec DevicesVasai(E), Thane, Maharashtra, IndiaContract manufacturer0000api.fda.gov
MEDITEC SOURCE GmbH & Co. KGTuttlingen-Nendingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Megadyne Medical Products, Inc.Cincinnati, OH, United StatesSpecification developer0000api.fda.gov
Mi3 LimitedBlackburn Lancashire, United KingdomContract manufacturer0000api.fda.gov
Ningbo Shun Ye Medical Company, Ltd.Cixi Ningbo Zhejiang, ChinaContract manufacturer0000api.fda.gov
PalliareGalway Galway(County), IrelandManufacturer0000api.fda.gov
PromedtechFouchena Tunis, TunisiaContract manufacturer0000api.fda.gov
Promepla S.A.MMONACO Monaco-Ville, MonacoManufacturer, Specification developer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Storz Endoskop Produktions GMBHSchaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesSpecification developer0000api.fda.gov
Surgease Innovations LtdBerkshire England, United KingdomManufacturer, Specification developer0000api.fda.gov
Symmetry Surgical GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.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
Unimax Medical Systems Inc.New Taipei City, TaiwanExporter to the US, Specification developer0000api.fda.gov
Unimax Medical Systems Inc.Yilan County, TaiwanManufacturer0000api.fda.gov
Unimicro Medical Systems (shenzhen) Co., Ltd.ShenZhen Guangdong, ChinaManufacturer0000api.fda.gov
Viant San Antonio, Inc.San Antonio, TX, United StatesManufacturer0000api.fda.gov
Zhejiang Shuyou Surgical Instrument Co., LtdHuzhou Zhejiang, ChinaManufacturer0000api.fda.gov

Updated November 2, 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.