510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K091574Substantially Equivalent

Silk Black Braided Surgical Sutures, Nylon Monofilament Blue and Black Surgical Sutures

Supplidores Unidos Internacionales, S.A., Coconut Creek FL / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091574 is the FDA 510(k) clearance record for SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES, a class II device, cleared for Supplidores Unidos Internacionales, S.A. on under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). FDA records list one 510(k) clearance for Supplidores Unidos Internacionales, S.A. As of , FDA records show no recalls naming K091574.

Clearance record

Decision date
Received
(129 days to decision)
Product code
GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Regulation
21 CFR 878.5000
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Supplidores Unidos Internacionales, S.A. P.O. Box 97-0132, Coconut Creek FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAT

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