510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K946267Substantially Equivalent

Gore-Tex Sam Facial Implant

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

K946267 is the FDA 510(k) clearance record for GORE-TEX SAM FACIAL IMPLANT, a class II device, cleared for W. L. Gore & Associates, Inc. on under FDA product code FWP (Prosthesis, Chin, Internal). FDA records list 169 510(k) clearances for W. L. Gore & Associates, Inc., from to . As of , FDA records show no recalls naming K946267.

Clearance record

Decision date
Received
(89 days to decision)
Product code
FWP Prosthesis, Chin, Internal
Regulation
21 CFR 878.3550
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 FWP

Trailing 12 months
1 clearance under product code FWP in the twelve months to November 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FWP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260