510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955364Substantially Equivalent

Seamguard Staple Line Reinforcement Material

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

K955364 is the FDA 510(k) clearance record for SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL, a class II device, cleared for W. L. Gore & Associates, Inc. on under FDA product code OXD (Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement). FDA's definition for product code OXD reads: "For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures". FDA records list 169 510(k) clearances for W. L. Gore & Associates, Inc., from to . As of , FDA records show no recalls naming K955364.

Clearance record

Decision date
Received
(71 days to decision)
Product code
OXD Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
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
Third party review
No

Clearances, product code OXD

Trailing 12 months

FDA records hold no clearances under product code OXD in the trailing twelve months.

FDA records show no clearances under product code OXD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OXD, 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