510(k) K180542
K180542 is an FDA 510(k) premarket notification submitted by Boston Endo Surgical Tech, for the device "NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe". The FDA issued a decision of Substantially Equivalent on August 22, 2018. The device falls under product code PDQ (Neurosurgical Nerve Locator), a Class II device regulated under 21 CFR 874.1820. Boston Endo Surgical Tech, has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2018
- Date Received
- March 1, 2018
- 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.