# K240776: Celsio Flexible Cryocatheter System

- Pathway: 510(k) (Traditional)
- Applicant: Endocision Technologies, Inc.
- Decided: Sep 24, 2024 after 187 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K934261 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190651: ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter, Erbe Elektromedizin GmbH (2020) Summary page 5.

## Indications for use
The Celsio Flexible Cryocatheter System is intended for cryoadhesion applications during interventional procedures such as the removal of tissue, foreign bodies, mucous plugs, blood clots, necrotic tissue, tumors and tissue biopsies, and for palliative devitalization (destruction) of tissue by the application of extreme cold.

Source page: https://510kreport.com/device/K240776
Methodology: https://510kreport.com/methodology