510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K926478Substantially Equivalent

Gore-Tek(r) Soft Tissue Patch

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

K926478 is the FDA 510(k) clearance record for GORE-TEK(R) SOFT TISSUE PATCH, 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 no recalls naming K926478.

Clearance record

Decision date
Received
(335 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. 3450 W. Kiltie Ln., Flagstaff AZ
510(k) summary
Summary
Third party review
No

Clearances, product code FTL

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