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Artoura Breast Tissue Expander

by Mentor Worldwide, LLC

510(k) K150777

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 12 Oct 2026. What this means

Regulatory status

as of registry sync 12 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK150777 Date24 Apr 2015ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1685-2026 FDA Class II initiated 18 Feb 2026

    Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

    • Terminated Z-2780-2016 FDA Class II initiated 9 Aug 2016

    The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.

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  • Withdrawn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

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