510(k) K123390
K123390 is an FDA 510(k) premarket notification submitted by Spineguard S.A. for the device "PEDIGUARD NERVE DETECTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on August 8, 2013. The device falls under product code PDQ (Neurosurgical Nerve Locator), a Class II device regulated under 21 CFR 874.1820. Spineguard S.A. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2013
- Date Received
- November 2, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurosurgical Nerve Locator
- Device Class
- Class II
- Regulation Number
- 874.1820
- Review Panel
- NE
- Submission Type
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.