510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900195Substantially Equivalent

Modified Gore-Tex Surgical Tape

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

K900195 is the FDA 510(k) clearance record for MODIFIED GORE-TEX SURGICAL TAPE, a class II device, cleared for W. L. Gore & Associates, Inc. on under FDA product code MCA (Tape, Surgical, Internal). FDA records list 169 510(k) clearances for W. L. Gore & Associates, Inc., from to . As of , FDA records show no recalls naming K900195.

Clearance record

Decision date
Received
(61 days to decision)
Product code
MCA Tape, Surgical, Internal
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
Third party review
No

Clearances, product code MCA

Trailing 12 months

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

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