510(k) K143420
K143420 is an FDA 510(k) premarket notification submitted by Imris, Inc. for the device "SYMBIS Surgical System". The FDA issued a decision of Substantially Equivalent on October 30, 2015. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Imris, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2015
- Date Received
- November 28, 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