510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053200Substantially Equivalent

Gore Seamguard Staple Line Reinforcement Material

W. L. Gore & Associates, Inc., Flagstaff AZ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053200 is the FDA 510(k) clearance record for GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL, a class II device, cleared for W. L. Gore & Associates, Inc. on under FDA product code FTL (Mesh, Surgical, Polymeric). FDA records list 169 510(k) clearances for W. L. Gore & Associates, Inc., from to . As of , FDA records show one recall naming K053200.

Clearance record

Decision date
Received
(21 days to decision)
Product code
FTL Mesh, Surgical, Polymeric
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
W. L. Gore & Associates, Inc. 3750 W. Kiltie Ln., Flagstaff AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FTL

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