# K231622: REGER Nebulizer Irrigation Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Reger Medizintechnik, GmbH
- Decided: Sep 29, 2023 after 119 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K963646 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222575: HurriChem Device Kit, Thermasolutions, LLC (2022) Summary page 5.

## Indications for use
The REGER Nebulizer Irrigation Cannula is indicated for use in patients undergoing a laparoscopic procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to lavage blood and tissue debris from the surgical site.

Source page: https://510kreport.com/device/K231622
Methodology: https://510kreport.com/methodology