510(k) K153306
K153306 is an FDA 510(k) premarket notification submitted by Orthovita, Inc. for the device "Imbibe Needle". The FDA issued a decision of Substantially Equivalent on December 18, 2015. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Orthovita, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2015
- Date Received
- November 16, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Biopsy
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- SU
- Submission Type