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Gynecare Morcellex Tissue Morcellator, Models MX0100 and MX0100R

by Ethicon Inc.

510(k) K061050

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK061050 Date14 Jul 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0173-2010 FDA Unclassified (pre-2012) initiated 28 Sep 2009

    There is the potential for the duckbill seal to become dislodged.

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  • Withdrawn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
HET
FDA applicant
ETHICON, Inc.
Device Class
Class II
Regulation
21 CFR Part 884.1720
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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