Product code GAS— General, Plastic Surgery

FDA has cleared 17 devices under product code GAS between 1990 and 2020, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20202 clearances
• 20101 clearance
• 20001 clearance
• 19961 clearance
• 19924 clearances
• 19914 clearances
• 19904 clearances

• Mitek Surgical Products, Inc.4 clearances
• United States Surgical, A Division of Tyco Healthc2 clearances
• Smith & Nephew, Inc.1 clearance
• Sharppoint, Inc.1 clearance
• Promedica Products, Inc.1 clearance
• Phoenix Biomedical Corp.1 clearance
• Lukens Medical Corp.1 clearance
• Lsi Solutions, Inc.1 clearance
• Lsi Solutions1 clearance
• Look, Inc.1 clearance

• K203081 — RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureLsi Solutions·2020-11-24
• K203120 — RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 PolypropyleneLsi Solutions, Inc.·2020-11-24
• K091018 — ARTHREX BIOWIREArthrex, Inc.·2010-07-30
• K002261 — MR-IIISmith & Nephew, Inc.·2000-10-23
• K953128 — SUTURE CORDPhoenix Biomedical Corp.·1996-02-09
• K923161 — BRAIDED POLYESTER SUTURE MATERIALMitek Surgical Products, Inc.·1992-12-30
• K913101 — PETERS CARDIOFLON(TM) SUTUREPromedica Products, Inc.·1992-08-12
• K915089 — MITEK QUICKANCHOR(TM), MODIFICATIONMitek Surgical Products, Inc.·1992-02-03
• K915081 — MITEK SNAP PAK(TM), MODIFICATIONMitek Surgical Products, Inc.·1992-01-31
• K903175 — ADVANCE SUTURE NONABSORBABLE DACRON SUTUREAdvance Suture, Inc.·1991-07-26
• K905285 — IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURESInternacional Farmaceutica, S.A. DE C.V.·1991-02-11
• K905440 — FINE SIZE NONABSORBABLE DACRON SURGICAL SUTUREUnited States Surgical, A Division of Tyco Healthc·1991-01-31
• K904535 — LU-TEX IILukens Medical Corp.·1991-01-30
• K904436 — QUICKANCHOR (TM)Mitek Surgical Products, Inc.·1990-12-11
• K904263 — DACRON R SURGICAL SUTURESSharppoint, Inc.·1990-10-16
• K904054 — POLYVIOLENE(TM) SUTURELook, Inc.·1990-10-03
• K902873 — NONABSORBABLE DACRON SURGICAL SUTURE*United States Surgical, A Division of Tyco Healthc·1990-09-27