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Acculis ACCU2I Pmta Applicator Model ACCU2I

by Microsulis Medical Limited

510(k) K094021

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 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 NumberK094021 Date6 Aug 2010ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-0529-2018 FDA Class II initiated 5 Jun 2017
    • Terminated Z-0526-2018 FDA Class II initiated 5 Jun 2017
    • Terminated Z-0528-2018 FDA Class II initiated 5 Jun 2017
    • Terminated Z-0531-2018 FDA Class II initiated 5 Jun 2017
    • Terminated Z-0530-2018 FDA Class II initiated 5 Jun 2017
    • Terminated Z-0527-2018 FDA Class II initiated 5 Jun 2017

    The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.

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  • Withdrawn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
NEY
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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