Home / 510(k) Clearances / K253698

510(k) K253698

Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes by Cooper Surgical — Product Code HHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2026
Date Received
November 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pessary, Vaginal
Device Class
Class II
Regulation Number
884.3575
Review Panel
OB
Submission Type

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Other clearances for product code HHW

  • K250438 — CooperSurgical Milex® Pessaries (April 11, 2025)
  • K240798 — Cntrl+ Bladder Support Pessary (December 17, 2024)
  • K232677 — Reia pessary (May 21, 2024)
  • K232525 — Yoni.Fit Bladder Support (May 17, 2024)
  • K233548 — Uresta® (April 3, 2024)
  • K231786 — Gynethotics™ Pessary (March 6, 2024)
  • K190277 — ProVate Vaginal Support (July 8, 2019)
  • K183468 — Revive Reusable Bladder Support (January 25, 2019)
  • K173351 — Panpac Flexi Shelf Pessary (October 31, 2018)
  • K153422 — Panpac Disposable Pessary Fitting Set (July 14, 2016)