Cleared Traditional

K180542 - NIM PAK Needle (FDA 510(k) Clearance)

Also includes:
NIM XPAK Needle NIM Pedicle Probe

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180542 · Boston Endo Surgical Tech, · Neurology device
Aug 2018
Decision
174d
Days
Class 2
Risk

K180542 is an FDA 510(k) clearance for the NIM PAK Needle. Classified as Neurosurgical Nerve Locator (product code PDQ), Class II - Special Controls.

Submitted by Boston Endo Surgical Tech, (Bridgeport, US). The FDA issued a Cleared decision on August 22, 2018 after a review of 174 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 874.1820 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K180542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2018
Decision Date August 22, 2018
Days to Decision 174 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 162d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDQ Neurosurgical Nerve Locator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
Definition To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.