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V-Go Insulin Delivery System

by Valeritas, Inc.

510(k) K103825

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

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 NumberK103825 Date23 Feb 2011ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-0199-2020 FDA Class II initiated 3 Jul 2019
    • Terminated Z-0198-2020 FDA Class II initiated 3 Jul 2019
    • Terminated Z-0195-2020 FDA Class II initiated 3 Jul 2019
    • Terminated Z-0196-2020 FDA Class II initiated 3 Jul 2019
    • Terminated Z-0197-2020 FDA Class II initiated 3 Jul 2019

    There is a potential for "No Needle Demo Units" to contain a needle.

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  • Withdrawn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
LZG
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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