510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GASClass II

Suture, Nonabsorbable, Synthetic, Polyester

21 CFR 878.5000 / General, Plastic Surgery
FDA source (opens on fda.gov)

GAS is the FDA product code for Suture, Nonabsorbable, Synthetic, Polyester, a class II device type, regulated under 21 CFR 878.5000. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GAS
Device name
Suture, Nonabsorbable, Synthetic, Polyester
Regulation
21 CFR 878.5000
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
17
Ingested recalls
1

Clearances, product code GAS

By decision year
17 clearances under product code GAS with a decision year between 1990 and 2020, 1990 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code GAS by decision year
YearClearances
19904
19914
19924
19961
20001
20101
20202

Applicants with the most clearances

Product code GAS
Applicants holding the most 510(k) clearances under product code GAS
ApplicantClearances
Mitek Surgical Products, Inc.4
Lsi Solutions Inc.2
United States Surgical, A Division of Tyco Healthc2
Advance Suture, Inc.1
Arthrex GmbH1
Internacional Farmaceutica, S.A. de C.V.1
Look, Inc.1
Lukens Medical Corp.1
Phoenix Biomedical Corp.1
Promedica Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 40 companies shown, in name order