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StimQ Peripheral Nerve Stimulator (PNS) System

by Stimq, LLC

510(k) K152178

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK152178 Date11 Mar 2016ClearedStatusActive

Recalls

6 recalls · 6 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-2929-2020 FDA Class II initiated 15 Jul 2020
    • Ongoing Z-2930-2020 FDA Class II initiated 15 Jul 2020
    • Ongoing Z-2932-2020 FDA Class II initiated 15 Jul 2020
    • Ongoing Z-2928-2020 FDA Class II initiated 15 Jul 2020
    • Ongoing Z-2931-2020 FDA Class II initiated 15 Jul 2020
    • Ongoing Z-2933-2020 FDA Class II initiated 15 Jul 2020

    The product contains a non-functional component not referenced in product labeling.

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  • Withdrawn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
GZF
Device Class
Class II
Regulation
21 CFR Part 882.5870
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent