510(k) K003958
K003958 is an FDA 510(k) premarket notification submitted by Coalescent Surgical for the device "COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE". The FDA issued a decision of Substantially Equivalent on February 6, 2001. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Coalescent Surgical has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 2001
- Date Received
- December 21, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type