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IcePearl 2.1 CX L, IceForce 2.1 CX L

by Galil Medical Ltd

510(k) K162599

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK162599 Date11 Oct 2016ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Completed Z-0662-2021 FDA Class II initiated 18 Nov 2020
    • Completed Z-0659-2021 FDA Class II initiated 18 Nov 2020 on shared 510(k) K162599

    Complaint trend regarding needle shaft gas leaks.

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  • Withdrawn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
GEH
FDA applicant
Galil Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4350
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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