510(k) K023089
K023089 is an FDA 510(k) premarket notification submitted by Biocure, Inc. for the device "GELSPHERES EMBOLIC AGENT". The FDA issued a decision of Substantially Equivalent on December 16, 2002. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Biocure, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2002
- Date Received
- September 17, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Neurovascular Embolization
- Device Class
- Class II
- Regulation Number
- 882.5950
- Review Panel
- NE
- Submission Type