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SurgiQuest AirSeal iFS System

by Surgiquest, Inc.

510(k) K143404

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

11 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 NumberK143404 Date20 Mar 2015ClearedStatusActive

Recalls

11 recalls · 11 ongoing · FDA

  • 11 recalls, same reason

    • Ongoing Z-2466-2026 FDA Class II initiated 14 May 2026
    • Ongoing Z-2471-2026 FDA Class II initiated 14 May 2026
    • Ongoing Z-2473-2026 FDA Class II initiated 14 May 2026
    • Ongoing Z-2464-2026 FDA Class II initiated 14 May 2026
    • Ongoing Z-2468-2026 FDA Class II initiated 14 May 2026
    • Ongoing Z-2467-2026 FDA Class II initiated 14 May 2026
    • Ongoing Z-2472-2026 FDA Class II initiated 14 May 2026
    • Ongoing Z-2470-2026 FDA Class II initiated 14 May 2026
    • Ongoing Z-2469-2026 FDA Class II initiated 14 May 2026
    • Ongoing Z-2465-2026 FDA Class II initiated 14 May 2026
    • Ongoing Z-2474-2026 FDA Class II initiated 14 May 2026

    Potential for overpressure alerts.

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  • Withdrawn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
HIF
Device Class
Class II
Regulation
21 CFR Part 884.1730
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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