# GEH: Unit, Cryosurgical, Accessories

- Device class: 2; regulation: 21 CFR 878.4350; FDA's rule: 510(k) required
- FDA decisions: 264
- 510(k) review time 2021–2025: median 88 days (middle half 40–180)
- Recalls: 74 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 12
- 2018: 6
- 2019: 6
- 2020: 8
- 2021: 6
- 2022: 6
- 2023: 8
- 2024: 9
- 2025: 10
- 2026: 8

## Most-cited predicates
- K211099: Freeze’n Clear Skin Clinic Warts & Tags (2022), cited by 7
- K023487: Histofreezer Wart Removal System or Other Proprietary Name (2003), cited by 7
- 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), cited by 6
- K140314: Wartie Wart Remover (2014), cited by 6
- K811390: CCS100 Cryosurgical System (1981), cited by 6
- K024009: Cryoprobe (2003), cited by 5
- K113860: Visual-Ice Cryoablation System (2012), cited by 5
- K121251: Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack (2012), cited by 4
- K152133: IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System (2015), cited by 4
- K112072: Atricure Cryo Module System (2011), cited by 4

Source page: https://510kreport.com/product-code/GEH
Data by year (CSV): https://510kreport.com/product-code/GEH.csv