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ARTOURA Breast Tissue Expanders with Smooth Surface

by Mentor Worldwide, LLC

510(k) K161176

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK161176 Date23 May 2016ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1687-2026 FDA Class II initiated 18 Feb 2026
    • Ongoing Z-1686-2026 FDA Class II initiated 18 Feb 2026

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

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  • Withdrawn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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