# K120590: Dilator Tube Set

- Pathway: 510(k) (Traditional)
- Applicant: Koros USA, Inc.
- Decided: May 7, 2013 after 434 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Dilator Tube Set is intended for use in surgical procedures to provide surgical access by dilating the soft tissue to the intended surgical site and to identify motor nerves, spinal nerve roots and to aid the surgeon in assessing nerve function during surgery. The Dilator Tube Set is single use only.

Source page: https://510kreport.com/device/K120590
Methodology: https://510kreport.com/methodology