510(k) K001576
K001576 is an FDA 510(k) premarket notification submitted by Prosurg, Inc. for the device "EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY". The FDA issued a decision of Substantially Equivalent on December 28, 2000. The device falls under product code NBV (Device, Engorgement, Clitoral), a Class II device regulated under 21 CFR 884.5970. Prosurg, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 2000
- Date Received
- May 22, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Engorgement, Clitoral
- Device Class
- Class II
- Regulation Number
- 884.5970
- Review Panel
- OB
- Submission Type