FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY
K Number: K001576
·
Decision Dec 28, 2000
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
16
Review Days
220
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Basic Information
- Device Name
- EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY
- K Number
- K001576
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5970
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Prosurg, Inc.
- Date Received
- May 22, 2000
- Decision Date
- December 28, 2000
- Product Code
- NBV
- 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 |
|---|---|---|---|
| NBV | Device, Engorgement, Clitoral | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NBV), ordered by most recent decision date.
ENHANCE CLITORAL STIMULATION AID
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EROS-CLITORAL THERAPY DEVICE (CTD)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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