510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K033671Substantially Equivalent

Gore Bioabsorbable Mesh

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

K033671 is the FDA 510(k) clearance record for GORE BIOABSORBABLE MESH, a class II device, cleared for W. L. Gore & Associates, Inc. on under FDA product code OWT (Mesh, Surgical, Absorbable, Abdominal Hernia). FDA's definition for product code OWT reads: "For reinforcement of soft tissue where weakness exists during hernia repair". FDA records list 169 510(k) clearances for W. L. Gore & Associates, Inc., from to . As of , FDA records show no recalls naming K033671.

Clearance record

Decision date
Received
(37 days to decision)
Product code
OWT Mesh, Surgical, Absorbable, Abdominal Hernia
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 PDF
Third party review
No

Clearances, product code OWT

Trailing 12 months

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

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