# K955011: Candela HCS 2000 Uretheral Warmer Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Candela Laser Corp.
- Decided: Apr 3, 1996 after 154 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.
No later device cites it as a predicate yet.
0 of 2 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). Our OCR of the scanned summary read K952595, FDA’s number for Haemophilus Test Medium (HTM) (Clinical Standards Laboratories, Inc.), decided Apr 10, 1996, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Cryomedical Sciences, Inc.’s CMS Urethral Warmer”.

## Indications for use
The Candela HCS 2000 Urethral Warmer Catheter System is designed to transfer heat into the urethral membrane during cryosurgical ablation of prostatic tissue using the Cryotech LCS 3000 Cryosurgical System.

Source page: https://510kreport.com/device/K955011
Methodology: https://510kreport.com/methodology