Cleared Traditional

K180542 - NIM PAK Needle

Also marketed or referenced as:
NIM XPAK Needle NIM Pedicle Probe

K180542 is an FDA 510(k) clearance for NIM PAK Needle, manufactured by Boston Endo Surgical Tech,. The device is a Class 2 Neurology device with product code PDQ cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K180542 · Boston Endo Surgical Tech, · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Boston Endo Surgical Tech, devices

FDA 510(k) Submission Details - K180542

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 148d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PDQ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - PDQ Neurosurgical Nerve Locator

All 23
Devices cleared under the same product code (PDQ) and FDA review panel - the closest regulatory comparables to K180542.
ATEC IOM Accessory Instruments
K182617 · Alphatec Spine, Inc. · May 2019
NAV PAK Needle, NIM NAV PAK Needle
K182662 · Boston Endo Surgical Tech, · Apr 2019
Neurosign V4 Intraoperative Nerve Monitor
K181559 · Magstim Company, Ltd. · Nov 2018
SENTIO MMG Gen 2
K173526 · Medos International SARL · Apr 2018
SENTIO MMG Pedicle Access Needles
K173134 · Medos International SARL · Mar 2018
ES2 Neuromonitoring Accessory Instruments
K171807 · Stryker Corporation · Jul 2017