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510(k) K182662

NAV PAK Needle, NIM NAV PAK Needle by Boston Endo Surgical Tech, — Product Code PDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2019
Date Received
September 25, 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.

Other clearances by Boston Endo Surgical Tech,

  • K180542 — NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe (August 22, 2018)

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  • K181559 — Neurosign V4 Intraoperative Nerve Monitor (November 9, 2018)