# K934261: Erbokryo CA Cryosurgical System

- Pathway: 510(k) (Traditional)
- Applicant: Erbe Elektromedizin GmbH
- Decided: Apr 26, 1994 after 238 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.
10 later devices descend from it; 1 cites it directly.
1 of 11 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
- K051509: Erbe Erbokryo CA Cryosurgical Unit & Accessories (2005), 9 descendants of its own
- K151041: ERBECRYO 2 Cryosurgical Unit with accessories (2015), 8 descendants of its own
- K190651: ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter (2020), 7 descendants of its own
- K253230: ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe (2026), 1 descendant of its own
- K240932: HybridTherm System (2024), 1 descendant of its own

Source page: https://510kreport.com/device/K934261
Methodology: https://510kreport.com/methodology