# K964971: Cryogen Cryosurgical System

- Pathway: 510(k) (Traditional)
- Applicant: Cryogen, Inc.
- Decided: Mar 28, 1997 after 106 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.
394 later devices descend from it; 1 cites it directly.
1 of 395 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K972662: Cryogen Cryosurgical System (1997), 393 descendants of its own
- K974320: Cryogen Cardiac Cryosurgical System (1998), 392 descendants of its own
- K013946: Flex 10 Accessory for the Afx Microwave Ablation System (2002), 340 descendants of its own
- K041340: Guidant Microwave Ablation System (2004), 268 descendants of its own
- K043153: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000 (2004), 251 descendants of its own

Source page: https://510kreport.com/device/K964971
Methodology: https://510kreport.com/methodology