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Gore-Tex Tunneler

by W. L. Gore & Associates, Inc.

510(k) K844584

Gore-Tex Tunneler is a Class I device made by W. L. Gore & Associates, Inc., cleared under FDA 510(k) K844584 on 24 Jan 1985, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK844584 Date24 Jan 1985ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DWS
Device class
Class I
Regulation
21 CFR Part 870.4500
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code DWS (Instruments, Surgical, Cardiovascular).

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