# K002615: Surgical System with Cryoguide

- Pathway: 510(k) (Traditional)
- Applicant: Endocare, Inc.
- Decided: Nov 13, 2000 after 83 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
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032333: Cryocare CS Surgical System (2003), 13 descendants of its own
- K050347: Modification to Cryocare CS Surgical System (2005), 12 descendants of its own
- K060279: Cryocare CS Surgical System (2006), 9 descendants of its own
- K101333: Cryocare CS Surgical System (2010), 8 descendants of its own
- K141110: Cryocare CS Surgical System (2015), 7 descendants of its own

Source page: https://510kreport.com/device/K002615
Methodology: https://510kreport.com/methodology