# K972662: Cryogen Cryosurgical System

- Pathway: 510(k) (Traditional)
- Applicant: Cryogen, Inc.
- Decided: Oct 1, 1997 after 90 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 K811390 (1981). 4 ancestors in all.
393 later devices descend from it; 1 cites it directly.
1 of 398 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811390: CCS100 Cryosurgical System, Frigitronics of Connecticut, Inc. (1981) Summary page 1.
- K904421: CMS Oncoprobe (TM), Cryomedical Sciences, Inc. (1991) Summary page 1.
- K953637: CMS Accuprobe 550/530, Cryomedical Sciences, Inc. (1995) Summary page 1.
- K964971: Cryogen Cryosurgical System, Cryogen, Inc. (1997) Summary page 1.
- (no number) Frigitronics CE-4 & CE-4G: named in the summary without a submission number

## Most influential descendants
- 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
- K050005: Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180 (2005), 231 descendants of its own

## Indications for use
The CryoGen Cryosurgical System is indicated for the ablation of tissue by the application of extreme cold in the areas of dermatology, general surgery, neurosurgery, thoracic surgery, E.N.T., gynecology, oncology, proctology and urology.

Source page: https://510kreport.com/device/K972662
Methodology: https://510kreport.com/methodology