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Data / Medical devices / Snare, Surgical

Snare, Surgical (GAE): 51 FDA-registered makers in 14 countries

51 establishments in 14 countries are registered with the FDA to make Snare, Surgical (product code GAE, Class 1, 21 CFR 878.4800). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on April 18, 1995, and lists 2 recall events (0 Class I). FDA data exported November 3, 2026.

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Product code
GAE
Device class
1
Regulation
878.4800
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States16
China9
Germany8
Pakistan7
Thailand2
Costa Rica1
Singapore1
Canada1
Dominican Republic1
Brazil1
Taiwan1
India1
Mexico1
France1

Makers of Snare, Surgical

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
Arthrocare CorporationCoyol Alajuela, Costa RicaManufacturer1June 1, 1988000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer1June 1, 1988000api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer1June 1, 1988000api.fda.gov
Acheron Instruments (pvt.) Ltd.LAHORE Punjab, PakistanManufacturer0000api.fda.gov
Andratec GMBHKoblenz Rhineland-Palatinate, GermanyManufacturer0000api.fda.gov
Anodyne SurgicalO Fallon, MO, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Anrei Medical (Hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaManufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Bothwin Medical Technology (SG) Pte. Ltd.Singapore Central Singapore, SingaporeSpecification developer0000api.fda.gov
Berger Surgical Medical Products GmbHNeuhausen ob Eck Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Bothwin (Beijing) Medical Technology Co., Ltd.Beijng Beijing, ChinaManufacturer0000api.fda.gov
Cixi Bohong Bath Appliances Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Coroneo, Inc.MONTREAL, QC Quebec, CanadaManufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Deroyal Intercontinental, S.R.L.Santiago, Dominican RepublicContract manufacturer0000api.fda.gov
Dewimed Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Elmed, Inc.Glendale Heights, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Edwards Lifesciences LLCDraper, UT, United StatesManufacturer0000api.fda.gov
Faga Medical Industria De Equipamentos E Instrumentos Medico Hospitalares Ltda MeBauru Sao Paulo, BrazilManufacturer0000api.fda.gov
Fortune Medical Instrument Corp.Taoyuan City, TaiwanManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
Gcmedica Enterprise Ltd. (wuxi)Wuxi Jiangsu, ChinaContract manufacturer0000api.fda.gov
Gcmedica Enterprise Ltd.(wuxi)WUXI Jiangsu, ChinaContract manufacturer0000api.fda.gov
Gesco Healthcare Private LimitedCHENNAI, Tamil Nadu, IndiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hive International Pvt Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer0000api.fda.gov
LivaNova USA, INC.Arvada, CO, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor0010api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.NAN JING Jiangsu, ChinaManufacturer0000api.fda.gov
Micro-Tech Medical Technology (Thailand) Co., Ltd.Bang Lamung District Chon Buri, ThailandManufacturer0000api.fda.gov
Ningbo Luke Medical Devices Co., Ltd.Yuyao Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Nopa Instruments, Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Peters SurgicalBOULOGNE-BILLANCOURT Hauts-de-Seine, FranceExporter to the US, Specification developer0000api.fda.gov
Peters Surgical International Co., LtdBangkok Krung Thep Maha Nakhon, ThailandContract manufacturer, Contract sterilizer0000api.fda.gov
PMS GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Quest Medical, Inc.Allen, TX, United StatesManufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Saint-Gobain Performance PlasticsPortage, WI, United StatesContract manufacturer0000api.fda.gov
Scanlan International, Inc.Saint Paul, MN, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Surgical Technologies, Inc.St. Paul, MN, United StatesContract manufacturer0000api.fda.gov
Surgicon Pvt LtdSialkot Punjab, PakistanManufacturer0000api.fda.gov
Volgo Care International (private) LimitedSialkot Punjab, PakistanContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Win Wings Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Zepf Medical Instruments GMBHSEITINGEN-OBERFLACHT Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov

Updated April 18, 1995. 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.