510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041514Substantially Equivalent

Truesilk Non-Absorbable Silk Surgical Suture

Sutures India Private Limited, Bangalore, IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041514 is the FDA 510(k) clearance record for TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE, a class II device, cleared for Sutures India Private Limited on under FDA product code GAP (Suture, Nonabsorbable, Silk). FDA records list 5 510(k) clearances for Sutures India Private Limited, from to . As of , FDA records show no recalls naming K041514.

Clearance record

Decision date
Received
(361 days to decision)
Product code
GAP Suture, Nonabsorbable, Silk
Regulation
21 CFR 878.5030
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Sutures India Private Limited 118, 3rd Phase, Bangalore, IN
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