510(k) DEN220009
DEN220009 is an FDA 510(k) premarket notification submitted by Intuitap Medical, Inc. for the device "VerTouch Spinal Imaging Device". The FDA issued a decision of De Novo Granted on January 19, 2024. The device falls under product code QXD (Spinal Imaging System For Neuraxial Procedures), a Class II device regulated under 21 CFR 868.1985.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- January 19, 2024
- Date Received
- February 1, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spinal Imaging System For Neuraxial Procedures
- Device Class
- Class II
- Regulation Number
- 868.1985
- Review Panel
- AN
- Submission Type
A spinal imaging system for neuraxial procedures is a sensor and software system that is used to assist in identification of the interspinous space for neuraxial procedures.