510(k) K140705
K140705 is an FDA 510(k) premarket notification submitted by Izi Medical Products for the device "NAVIGABLE BRAIN BIOPSY CANNULA SET". The FDA issued a decision of Substantially Equivalent on December 5, 2014. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Izi Medical Products has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2014
- Date Received
- March 21, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurological Stereotaxic Instrument
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- NE
- Submission Type