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Habib 4X

by Emcision, Ltd.

510(k) K051420

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK051420 Date15 Aug 2005ClearedStatusActive

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-3073-2011 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-3074-2011 FDA Unclassified (pre-2012) initiated 30 Aug 2010

    The labeling contains errors which result in the products being misbranded

    • Terminated Z-0031-06 FDA Unclassified (pre-2012) initiated 21 Sep 2005

    Devices for which sterility may be compromised as evidenced by a loss of package integrity.

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  • Withdrawn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
GEI
FDA applicant
Emcision , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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