Eva -Vacuum Assist Device for Clitoral Therapy
FDA 510(k) K001576 · Prosurg, Inc.
510(k) numberK001576
Submission
- Device name
- Eva -Vacuum Assist Device for Clitoral Therapy
- Applicant
- Prosurg, Inc.
San Jose, CA, US - Received
- May 22, 2000
- Decision date
- December 28, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NBV – Device, Engorgement, Clitoral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5970
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code NBV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K043480 | Enhance Clitoral Stimulation AidNBV · Traditional | Gynavations, Inc. | 06/08/2005SE |
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Questions and answers
When was Eva -Vacuum Assist Device for Clitoral Therapy cleared by the FDA?
Eva -Vacuum Assist Device for Clitoral Therapy (K001576) received a 510(k) decision of Substantially Equivalent on December 28, 2000, 220 days after the submission was received.
What is the product code of K001576?
The FDA product code is NBV – Device, Engorgement, Clitoral, a Class II (moderate risk) device regulated under 21 CFR 884.5970.