510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K241486Substantially Equivalent

Sofsilk™ Coated Braided Silk Suture

Medtronic, Inc., North Haven CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K241486 is the FDA 510(k) clearance record for Sofsilk™ Coated Braided Silk Suture, a class II device, cleared for Covidien on under FDA product code GAP (Suture, Nonabsorbable, Silk). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K241486.

Clearance record

Decision date
Received
(193 days to decision)
Product code
GAP Suture, Nonabsorbable, Silk
Regulation
21 CFR 878.5030
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Covidien 60 Middletown Ave., North Haven CT
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