FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Intimate Rose Vaginal Dilators
K Number: K231430
·
Decision Jun 7, 2023
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
8
Applicant Total
3
Review Days
21
Basic Information
- Device Name
- Intimate Rose Vaginal Dilators
- K Number
- K231430
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.3900
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Plus EV Holdings dba Intimate Rose
- Date Received
- May 17, 2023
- Decision Date
- June 7, 2023
- Product Code
- HDX
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HDX | Dilator, Vaginal | FDA class 2 | Obstetrics/Gynecology |
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