510(k) K113533
K113533 is an FDA 510(k) premarket notification submitted by Baxano, Inc. for the device "NEURO CHECK DEVICE WITH IO-FLEX WIRE". The FDA issued a decision of Substantially Equivalent on April 11, 2012. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. Baxano, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2012
- Date Received
- November 30, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rongeur, Manual
- Device Class
- Class II
- Regulation Number
- 882.4840
- Review Panel
- NE
- Submission Type