FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Yoni.Fit Bladder Support
K Number: K232525
·
Decision May 17, 2024
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
40
Applicant Total
1
Review Days
270
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Basic Information
- Device Name
- Yoni.Fit Bladder Support
- K Number
- K232525
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.3575
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Watkins-Conti Products, Inc.
- Date Received
- August 21, 2023
- Decision Date
- May 17, 2024
- Product Code
- HHW
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HHW | Pessary, Vaginal | FDA class 2 | Obstetrics/Gynecology |
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