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
K024091Substantially Equivalent

Silk Sutures

Aurolab, Madison WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K024091 is the FDA 510(k) clearance record for SILK SUTURES, a class II device, cleared for Aurolab on under FDA product code GAP (Suture, Nonabsorbable, Silk). FDA records list 4 510(k) clearances for Aurolab, from to . As of , FDA records show no recalls naming K024091.

Clearance record

Decision date
Received
(79 days to decision)
Product code
GAP Suture, Nonabsorbable, Silk
Regulation
21 CFR 878.5030
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Aurolab 6441 Enterprise Ln., Madison WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAP

Trailing 12 months

FDA records hold no clearances under product code GAP in the trailing twelve months.

FDA records show no clearances under product code GAP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GAP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260