# K182662: NAV PAK Needle, NIM NAV PAK Needle

- Pathway: 510(k) (Traditional)
- Applicant: Boston Endo Surgical Tech,
- Decided: Apr 10, 2019 after 197 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: 5 generations back to K980148 (1998). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180542: NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe, Boston Endo Surgical Tech, (2018) Summary page 4.
- K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 4.

## Indications for use
The BE-ST NAV PAK is indicated for navigated pedicle pilot hole preparation. The BE-ST NAV PAK should only be used with a compatible Medtronic StealthStation® System. The BE-ST NAV NIM® PAK is indicated for navigated pedicle pilot hole preparation, locating, and identifying nerves during surgery, including spinal nerve roots. The BE-ST NAV NIM® PAK should only be used with compatible Medtronic StealthStation® and Medtronic NIM® Systems.

Source page: https://510kreport.com/device/K182662
Methodology: https://510kreport.com/methodology