# K980913: Cryo-Hit Model Numbers EP3T3, EP5T2, EP5T5, EP7T5, EP8T5

- Pathway: 510(k) (Traditional)
- Applicant: Galil Medical, Ltd.
- Decided: Jul 1, 1998 after 113 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
153 later devices descend from it; 4 cite it directly.
0 of 154 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CRYOcare - ENDOcare: named in the summary without a submission number
- (no number) CMS AccuProbe System: named in the summary without a submission number

## Most influential descendants
- K991517: Cryo-Hit II, Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 (1999), 125 descendants of its own
- K993965: Cryo-Hit (2000), 123 descendants of its own
- K011722: Atricure Bipolar Coagulation System (2001), 92 descendants of its own
- K020919: Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 (2002), 90 descendants of its own
- K040690: Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console (2004), 42 descendants of its own

## Indications for use
CRYO-HIT™ is intended for cryogenic destruction of tissue during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurosurgery, thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue, ihcluding liver metastases, skin lesions, warts, and prostate tissue.

Source page: https://510kreport.com/device/K980913
Methodology: https://510kreport.com/methodology