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510(k) K231786

Gynethotics™ Pessary by Cosm Medical — Product Code HHW

K231786 is an FDA 510(k) premarket notification submitted by Cosm Medical for the device "Gynethotics™ Pessary". The FDA issued a decision of Substantially Equivalent on March 6, 2024. The device falls under product code HHW (Pessary, Vaginal), a Class II device regulated under 21 CFR 884.3575.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2024
Date Received
June 20, 2023
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

Other clearances for product code HHW

  • K253698 — Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Supp (January 20, 2026)
  • 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)
  • 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)

FDA data resources