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Sonopet Model Ust-2001 Ultrasonic Surgical Aspirator

by Mutoh America Co., Ltd.

510(k) K010309

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK010309 Date18 Apr 2001ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-2156-2014 FDA Class II initiated 24 Jun 2014

    The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip.

  • 3 recalls, same reason

    • Terminated Z-1880-2013 FDA Class II initiated 24 Jun 2013
    • Terminated Z-1878-2013 FDA Class II initiated 24 Jun 2013
    • Terminated Z-1879-2013 FDA Class II initiated 24 Jun 2013

    A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation pump is to supply sali

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  • Withdrawn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
LFL
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent