# K935010: Wallach Ultra Freeze

- Pathway: 510(k) (Traditional)
- Applicant: Wallach Surgical Devices, Inc.
- Decided: Feb 9, 1994 after 112 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.
18 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have 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
- K040809: Crymed Cryo-Ablator (2004), 16 descendants of its own
- K060555: Spraygenix Cryo Ablation System (2006), 15 descendants of its own
- K070893: Cryospray Ablation System, Model CU 8407020500 (2007), 13 descendants of its own
- K101825: Cryoballoon Ablation System (2010), 11 descendants of its own
- K131523: Cryoballoon Focal Ablation System (2013), 10 descendants of its own

Source page: https://510kreport.com/device/K935010
Methodology: https://510kreport.com/methodology