510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222919Substantially Equivalent

GORE® ENFORM Biomaterial

W. L. Gore & Associates, Inc., Elkton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222919 is the FDA 510(k) clearance record for GORE® ENFORM Biomaterial, a class II device, cleared for W. L. Gore and Associates, Inc. on under FDA product code OXF (Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery). FDA's definition for product code OXF reads: "For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery". FDA records list 169 510(k) clearances for W. L. Gore and Associates, Inc., from to . As of , FDA records show no recalls naming K222919.

Clearance record

Decision date
Received
(84 days to decision)
Product code
OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
W. L. Gore and Associates, Inc. 301 Airport Rd., Elkton MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OXF

Trailing 12 months

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

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