# K963970: Endocare Cryocare Cryosurgical System Urethral Warming System

- Pathway: 510(k) (Traditional)
- Applicant: Endocare, Inc.
- Decided: Feb 25, 1997 after 145 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: 1 generation back to K952895 (1995). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952895: CMS Urethral Warmer, Cryomedical Sciences, Inc. (1995) Summary page 1.

## Most influential descendants
- K211149: Urethral Warming Catheter Kit (2022), 0 descendants of its own
- K090978: UC-Care Warming System (2009), 0 descendants of its own

## Indications for use
The ENDOcare Urethral Warming System is an accessory to the cryosurgical system and is indicated to transfer heat to the urethral tissue during urological cryosurgery procedures using the ENDOcare CRYOcare™ Cryosurgical System.

Source page: https://510kreport.com/device/K963970
Methodology: https://510kreport.com/methodology