510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961802Substantially Equivalent

Preclude Synbloc Membrane

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

K961802 is the FDA 510(k) clearance record for PRECLUDE SYNBLOC MEMBRANE, a class II device, cleared for W. L. Gore & Associates, Inc. on under FDA product code GXO (Strip, Craniosynostosis, Preformed). FDA records list 169 510(k) clearances for W. L. Gore & Associates, Inc., from to . As of , FDA records show no recalls naming K961802.

Clearance record

Decision date
Received
(83 days to decision)
Product code
GXO Strip, Craniosynostosis, Preformed
Regulation
21 CFR 882.5900
Device class
Class II
Review panel
Neurology
Applicant
W. L. Gore & Associates, Inc. 301 Airport Rd., Elkton MD
510(k) summary
Summary
Third party review
No

Clearances, product code GXO

Trailing 12 months

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

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