510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K021477Substantially Equivalent

Preclude Mvp Dura Substitute

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

K021477 is the FDA 510(k) clearance record for PRECLUDE MVP DURA SUBSTITUTE, a class II device, cleared for W. L. Gore & Associates, Inc. on under FDA product code GXQ (Dura Substitute). FDA records list 169 510(k) clearances for W. L. Gore & Associates, Inc., from to . As of , FDA records show no recalls naming K021477.

Clearance record

Decision date
Received
(184 days to decision)
Product code
GXQ Dura Substitute
Regulation
21 CFR 882.5910
Device class
Class II
Review panel
Neurology
Applicant
W. L. Gore & Associates, Inc. 3450 W. Kiltie Ln., Flagstaff AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXQ

Trailing 12 months

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

FDA records show no clearances under product code GXQ in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GXQ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260