GAS — Suture, Nonabsorbable, Synthetic, Polyester Class II

FDA Device Classification

Classification Details

Product Code
GAS
Device Class
Class II
Regulation Number
878.5000
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K203120lsi solutionsRD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIKNovember 24, 2020
K203081lsi solutionsRAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureNovember 24, 2020
K091018arthrexARTHREX BIOWIREJuly 30, 2010
K002261smith and nephewMR-IIIOctober 23, 2000
K953128phoenix biomedicalSUTURE CORDFebruary 9, 1996
K923161mitek surgical productsBRAIDED POLYESTER SUTURE MATERIALDecember 30, 1992
K913101promedica productsPETERS CARDIOFLON(TM) SUTUREAugust 12, 1992
K915089mitek surgical productsMITEK QUICKANCHOR(TM), MODIFICATIONFebruary 3, 1992
K915081mitek surgical productsMITEK SNAP PAK(TM), MODIFICATIONJanuary 31, 1992
K903175advance sutureADVANCE SUTURE NONABSORBABLE DACRON SUTUREJuly 26, 1991
K905285internacional farmaceutica, s.a. de c.vIFSA STERILE BRAIDED POLY NONABSOR SURG SUTURESFebruary 11, 1991
K905440united states surgical, a division of tyco healthcFINE SIZE NONABSORBABLE DACRON SURGICAL SUTUREJanuary 31, 1991
K904535lukens medicalLU-TEX IIJanuary 30, 1991
K904436mitek surgical productsQUICKANCHOR (TM)December 11, 1990
K904263sharppointDACRON R SURGICAL SUTURESOctober 16, 1990
K904054lookPOLYVIOLENE(TM) SUTUREOctober 3, 1990
K902873united states surgical, a division of tyco healthcNONABSORBABLE DACRON SURGICAL SUTURE*September 27, 1990