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Data / Medical devices / Suture, Nonabsorbable, Synthetic, Polyester

Suture, Nonabsorbable, Synthetic, Polyester (GAS): 22 FDA-registered makers in 5 countries

22 establishments in 5 countries are registered with the FDA to make Suture, Nonabsorbable, Synthetic, Polyester (product code GAS, Class 2, 21 CFR 878.5000). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on November 24, 2020, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Get every maker of this deviceMakers in the United StatesWatch this device
Product code
GAS
Device class
2
Regulation
878.5000
Medical specialty
General, Plastic Surgery
Implant
Yes

Makers by country

CountryMakers
United States16
Mexico3
Switzerland1
India1
United Kingdom1

Makers of Suture, Nonabsorbable, Synthetic, Polyester

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
Lsi Solutions Inc.Victor, NY, United StatesManufacturer2November 24, 2020000api.fda.gov
Internacional Farmaceutica, S.A. De C.V.Mexico City, MexicoManufacturer1February 11, 1991000api.fda.gov
Internacional Farmaceutica, S.A. De C.V.LERMA Mexico, MexicoManufacturer1February 11, 1991000api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer1October 23, 2000000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Alcon Research, LLCSinking Spring, PA, United StatesManufacturer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer0000api.fda.gov
Meril Endo Surgery Pvt. Ltd.Vapi Gujarat, IndiaContract manufacturer0000api.fda.gov
Performance Fibers OEM LLCMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Riverpoint Medical LLCPortland, OR, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)Birmingham, AL, United StatesSpecification developer0000api.fda.gov
Surgical Specialties Corporation Limited (UK)Taunton Somerset, United KingdomContract manufacturer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Tesco Associates, Inc.Tyngsboro, MA, United StatesContract manufacturer0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Teleflex Medical de Mexico, S. de R.L. de C.V.NUEVO LAREDO Tamaulipas, MexicoContract manufacturer0000api.fda.gov
Visionary Medical Supplies, Inc.Madison, WI, United StatesManufacturer for export0000api.fda.gov

Updated November 24, 2020. 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.