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

Suture, Nonabsorbable, Synthetic, Polyethylene

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

GAT is the FDA product code for Suture, Nonabsorbable, Synthetic, Polyethylene, a class II device type, regulated under 21 CFR 878.5000. As of , FDA records hold 176 510(k) clearances under this code, the most recent dated , and 23 recalls.

Classification record

Product code
GAT
Device name
Suture, Nonabsorbable, Synthetic, Polyethylene
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
176
Ingested recalls
23

Clearances, product code GAT

By decision year
176 clearances under product code GAT with a decision year between 1993 and 2026, 2004 the highest year at 13.
Show the numbers
510(k) clearances under FDA product code GAT by decision year
YearClearances
19936
19945
19964
19971
19982
19993
20005
20015
20025
20032
200413
20053
20069
20076
20084
20099
201011
20111
20126
20134
20144
20157
201610
20176
20186
20194
20205
20214
20225
20238
20243
20255
20265

Applicants with the most clearances

Product code GAT
Applicants holding the most 510(k) clearances under product code GAT
ApplicantClearances
Arthrex GmbH19
Smith & Nephew, Inc.11
Riverpoint Medical, LLC7
Teleflex Medical6
Medos International SARL5
Threadstone LLC5
Anulex Technologies, Inc.4
Sentreheart, Inc.4
Teleflexmedical, Inc.4
Usgi Medical4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 207 companies shown, in name order