510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K101377Substantially Equivalent

Smith & Newphew Ultrabraid II Suture

Smith & Newphew, Inc., Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101377 is the FDA 510(k) clearance record for SMITH & NEWPHEW ULTRABRAID II SUTURE, a class II device, cleared for Smith & Newphew, Inc. on under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). FDA records list 2 510(k) clearances for Smith & Newphew, Inc., from to . As of , FDA records show no recalls naming K101377.

Clearance record

Decision date
Received
(326 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
Smith & Newphew, Inc. 150 Minutemand Rd., Andover MA
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