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Miniscav

by Sedation Systems LLC

510(k) K160950

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K160950; other models may be affected

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK160950 Date5 May 2017ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2619-2023 FDA Class II initiated 23 Aug 2023 on shared 510(k) K160950

    Inadequate documentation of acceptance activity

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
CBN
FDA applicant
Sedation Systems, LLC
Device Class
Class II
Regulation
21 CFR Part 868.5430
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent