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Signal Gear Urethral Catheter Electrode

by Neurovision Medical Products, Inc.

510(k) K113771

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK113771 Date13 Dec 2012ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1968-2021 FDA Class II initiated 8 Apr 2021
    • Terminated Z-1970-2021 FDA Class II initiated 8 Apr 2021

    The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

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  • Withdrawn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
FAP
Device Class
Class II
Regulation
21 CFR Part 876.1620
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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