# K211909: Cysto-Gastro-Sets

- Pathway: 510(k) (Traditional)
- Applicant: G-Flex Europe Sprl
- Decided: Jun 9, 2022 after 353 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- 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 K970053 (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)
- K022595: Wilson-Cook Cystotome, Wilson-Cook Medical, Inc. (2002) Summary page 4.

## Indications for use
Cysto-Gastro Sets are intended to be used to electrosurgically cannulate pancreatic pseudo-cysts endoscopically (via the transgastric or transduodenal wall) as an alternative to surgical or percutaneous treatment.

Source page: https://510kreport.com/device/K211909
Methodology: https://510kreport.com/methodology