510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K844584Substantially Equivalent

Gore-Tex Tunneler

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

K844584 is the FDA 510(k) clearance record for GORE-TEX TUNNELER, a class I device, cleared for W. L. Gore & Associates, Inc. on under FDA product code DWS (Instruments, Surgical, Cardiovascular). FDA records list 169 510(k) clearances for W. L. Gore & Associates, Inc., from to . As of , FDA records show no recalls naming K844584.

Clearance record

Decision date
Received
(62 days to decision)
Product code
DWS Instruments, Surgical, Cardiovascular
Regulation
21 CFR 870.4500
Device class
Class I
Review panel
Cardiovascular
Applicant
W. L. Gore & Associates, Inc. 3450 W. Kiltie Ln., Flagstaff AZ
Third party review
No

Clearances, product code DWS

Trailing 12 months

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

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