# K003811: Cryocare Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Endocare, Inc.
- Decided: Oct 11, 2001 after 304 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.
39 later devices descend from it; 3 cite it directly.
0 of 40 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
- K020605: Sanarus Visica Treatment System (2002), 31 descendants of its own
- K021211: Modification to Sanarus Visica Treatment System (2002), 30 descendants of its own
- K022314: Sanarus Visica Treatment System (2002), 29 descendants of its own
- K052861: Modification to:Sanarus Visica Treatment System , Models VS2000 (2005), 28 descendants of its own
- K061510: Sanarus Visica Treatment System (2006), 27 descendants of its own

Source page: https://510kreport.com/device/K003811
Methodology: https://510kreport.com/methodology