510(k) K100836
K100836 is an FDA 510(k) premarket notification submitted by Surgivision, Inc. for the device "CLEARPOINT SYSTEM". The FDA issued a decision of Substantially Equivalent on June 16, 2010. The device falls under product code ORR (Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri), a Class II device regulated under 21 CFR 882.4560. Surgivision, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 2010
- Date Received
- March 24, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- NE
- Submission Type
To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.