510(k) K021745
K021745 is an FDA 510(k) premarket notification submitted by Vmbc, LLC for the device "VASCLIP". The FDA issued a decision of SESU on August 20, 2002. The device falls under product code NJC (Clip, Vas Deferens), a Class II device regulated under 21 CFR 878.4300.
Clearance Details
- Decision
- SESU ()
- Decision Date
- August 20, 2002
- Date Received
- May 28, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Vas Deferens
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type
This is an implantable clip intended to ligate the vas deferens. This is more specific than the regulation.