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
K926168Substantially Equivalent

Silk Sutures-Revised Labeling

Look, Inc., Ada OK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K926168 is the FDA 510(k) clearance record for SILK SUTURES-REVISED LABELING, a class II device, cleared for Look, Inc. on under FDA product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide). FDA records list 12 510(k) clearances for Look, Inc., from to . As of , FDA records show no recalls naming K926168.

Clearance record

Decision date
Received
(381 days to decision)
Product code
GAR Suture, Nonabsorbable, Synthetic, Polyamide
Regulation
21 CFR 878.5020
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Look, Inc. 2020 Lonnie Abbott Ind. Blvd., Ada OK
510(k) summary
Statement
Third party review
No

Clearances, product code GAR

Trailing 12 months
1 clearance under product code GAR in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GAR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260