# K211149: Urethral Warming Catheter Kit

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jan 5, 2022 after 261 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: 2 generations back to K952895 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963970: Endocare Cryocare Cryosurgical System Urethral Warming System, Endocare, Inc. (1997) Summary page 4.

## Indications for use
The Varian Urethral Warming Catheter Kit, a set of disposable components used in conjunction with a warmer system, sterile water or saline, and peristaltic pump, is intended to transfer heat to urethra during urological cryosurgery with Varian CRYOCARE Systems.

Source page: https://510kreport.com/device/K211149
Methodology: https://510kreport.com/methodology