510(k) K232525

Yoni.Fit Bladder Support by Watkins-Conti Products, Inc. — Product Code HHW

K232525 is an FDA 510(k) premarket notification submitted by Watkins-Conti Products, Inc. for the device "Yoni.Fit Bladder Support". The FDA issued a decision of Substantially Equivalent on May 17, 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
May 17, 2024
Date Received
August 21, 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