# K160297: Tuohy NRFit

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Oct 28, 2016 after 268 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K932249 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040965: Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles, Pajunk GmbH (2004) Summary page 5.

## Indications for use
The Tuohy NRFit™ cannulas/ needles for anesthesia and analgesia are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia or to facilitate placement of an epidural catheter. The device is intended for adult and pediatric patients.

Source page: https://510kreport.com/device/K160297
Methodology: https://510kreport.com/methodology