FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Hope&Her Vaginal Dilators
K Number: K233689
·
Decision May 2, 2024
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
8
Applicant Total
2
Review Days
167
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Basic Information
- Device Name
- Hope&Her Vaginal Dilators
- K Number
- K233689
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.3900
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lujena, Inc.
- Date Received
- November 17, 2023
- Decision Date
- May 2, 2024
- Product Code
- HDX
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HDX | Dilator, Vaginal | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HDX), ordered by most recent decision date.
Intimate Rose Vaginal Dilators
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PANPAC VAGINAL DILATORS
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FDA Class 2
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Other Clearances by Lujena, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K222492 | Hope&Her Vaginal Dilators | Jun 27, 2023 | Substantially Equivalent |