# K180542: NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe

- Pathway: 510(k) (Traditional)
- Applicant: Boston Endo Surgical Tech,
- Decided: Aug 22, 2018 after 174 days
- Product code: PDQ (Neurosurgical Nerve Locator)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K980148 (1998). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031003: Stimulus/Dissection Instruments, Ball-Tip Probes, Medtronic Xomed, Inc. (2003) Summary page 4.
- K031510: Nim-Spine, Medtronic Xomed (2003) Summary page 4.

## Most influential descendants
- K182662: NAV PAK Needle, NIM NAV PAK Needle (2019), 0 descendants of its own

## Indications for use
The BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe are indicated for pedicle pilot hole preparation, locating, and identifying cranial and peripheral motor nerves during surgery, including spinal nerve roots.

Source page: https://510kreport.com/device/K180542
Methodology: https://510kreport.com/methodology