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Cusa Excel+ Ultrasonic Surgical Aspirator System

by Integra Lifesciences Corporation 3 variants

510(k) K141674

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 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 NumberK141674 Date6 Nov 2014ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2167-2024 FDA Class II initiated 29 May 2024

    Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment

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  • Withdrawn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

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