510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
GAPClass II

Suture, Nonabsorbable, Silk

21 CFR 878.5030 / General, Plastic Surgery
FDA source (opens on fda.gov)

GAP is the FDA product code for Suture, Nonabsorbable, Silk, a class II device type, regulated under 21 CFR 878.5030. As of , FDA records hold 41 510(k) clearances under this code, the most recent dated , and 28 recalls.

Classification record

Product code
GAP
Device name
Suture, Nonabsorbable, Silk
Regulation
21 CFR 878.5030
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
41
Ingested recalls
28

Clearances, product code GAP

By decision year
41 clearances under product code GAP with a decision year between 1976 and 2024, 1994 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code GAP by decision year
YearClearances
19762
19771
19902
19912
19946
19961
19971
19982
19992
20005
20011
20022
20031
20041
20051
20061
20071
20081
20162
20171
20181
20231
20243

Applicants with the most clearances

Product code GAP
Applicants holding the most 510(k) clearances under product code GAP
ApplicantClearances
United States Surgical, A Division of Tyco Healthc5
M/s. Meril Endo Surgery Private Limited.2
Safepath Medical, Inc.2
Surgical Specialties Corp2
Advance Suture, Inc.1
Aesculap Inc1
Alcon Laboratories1
Arc Medical Supplies (Beijing) Co, Ltd.1
Arrow Intl., Inc.1
Aurolab1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 103 companies shown, in name order