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Milex MXKPINFXL

by CooperSurgical, Inc.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

13 closed

Documents

510(k) K904026

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number60888937008137 UDI-DI Date2 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK904026 Date10 Oct 1990DecidedStatusActive

Recalls

13 recalls · FDA

    • Terminated Z-2054-2017 FDA Class II initiated 10 Apr 2017

    The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the Instructions for Use (IFU) correctly states that the pessary is manufactured from latex rubber.

    • Terminated Z-1239-2015 FDA Class II initiated 9 Feb 2015

    Incorrect size printed on the Milex Pessary Kit packaging label

  • 2 recalls, same reason

    • Terminated Z-0208-2015 FDA Class III initiated 30 Sep 2014
    • Terminated Z-0207-2015 FDA Class III initiated 30 Sep 2014

    Incorrect expiration date printed on the MILEX PESSARY KIT packaging

  • 9 recalls, same reason

    • Terminated Z-1008-2013 FDA Class III initiated 26 Feb 2013
    • Terminated Z-1011-2013 FDA Class III initiated 26 Feb 2013
    • Terminated Z-1004-2013 FDA Class III initiated 26 Feb 2013
    • Terminated Z-1007-2013 FDA Class III initiated 26 Feb 2013
    • Terminated Z-1012-2013 FDA Class III initiated 26 Feb 2013
    • Terminated Z-1005-2013 FDA Class III initiated 26 Feb 2013
    • Terminated Z-1010-2013 FDA Class III initiated 26 Feb 2013
    • Terminated Z-1006-2013 FDA Class III initiated 26 Feb 2013
    • Terminated Z-1009-2013 FDA Class III initiated 26 Feb 2013

    Pessary mislabeled outer package may not reflect the size of the product contained in the package

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Milex
Generic name
Pelvic-organ-supporting pessary
Model / reference
MXKPINFXL
Primary DI / UDI-DI
60888937008137
510(k) Number
FDA product code
HHW
GMDN term
Pelvic-organ-supporting pessary
Device class
Class II
Regulation number
884.3575
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pelvic-organ-supporting pessary

Cleared under the same submission (K904026)

Show all (12)

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties

  • Single use
  • Contains latex
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Over-the-counter: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No