510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K920998Substantially Equivalent

Gore Tunneler, Modification

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

K920998 is the FDA 510(k) clearance record for GORE TUNNELER, MODIFICATION, a class II device, cleared for W. L. Gore & Associates, Inc. on under FDA product code DYB (Introducer, Catheter). FDA records list 169 510(k) clearances for W. L. Gore & Associates, Inc., from to . As of , FDA records show no recalls naming K920998.

Clearance record

Decision date
Received
(93 days to decision)
Product code
DYB Introducer, Catheter
Regulation
21 CFR 870.1340
Device class
Class II
Review panel
Cardiovascular
Applicant
W. L. Gore & Associates, Inc. 1505 N. Fourth St., Flagstaff AZ
510(k) summary
Summary
Third party review
No

Clearances, product code DYB

Trailing 12 months
19 clearances under product code DYB in the twelve months to November 2026, April 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code DYB, trailing twelve months
MonthClearances
December 20252
January 20261
February 20262
March 20261
April 20267
May 20260
June 20263
July 20262
August 20260
September 20260
October 20261
November 20260