510(k) K994160
K994160 is an FDA 510(k) premarket notification submitted by Coalescent Surgical for the device "COALESCENT SURGICAL SUTURED-CLIP". The FDA issued a decision of Substantially Equivalent on February 4, 2000. 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 4, 2000
- Date Received
- December 9, 1999
- 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