# K160296: SPROTTE SPECIAL NRFit

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Oct 27, 2016 after 267 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: 1 generation back to K911221 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911221: Atraumatic Special Sprotte Needle, Pajunk GmbH (1992) Summary page 5.

## Indications for use
The SPROTTE® SPECIAL NRFit™ anaesthesia conduction needle is intended to gain entry into the spinal canal to apply single shot spinal anaesthesia. It has an opening which will allow the introduction of a catheter which is used to inject anaesthetics to provide continuous spinal anaesthesia. The device is intended for adult and pediatric patients.

Source page: https://510kreport.com/device/K160296
Methodology: https://510kreport.com/methodology