# K110754: Cryopen Cryosurgical System, K102214

- Pathway: 510(k) (Traditional)
- Applicant: Cryopen, Inc.
- Decided: Sep 9, 2011 after 175 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 K803311 (1981). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K803311: LL100 Cryosurgical System, Wallach Surgical Devices, Inc. (1981) Summary page 3.

## Most influential descendants
- K161480: R2 Dermal Cooling System (2016), 5 descendants of its own
- K171398: Dermal Cooling System (2017), 4 descendants of its own
- K201260: Dermal Cooling System (2020), 3 descendants of its own
- K203006: R2 Dermabrasion Tip (for Dermal Cooling System) (2021), 2 descendants of its own
- K213294: Dermal Cooling System (2022), 1 descendant of its own

## Indications for use
Cryosurgical unit used for ablative type surgical technique on mfultiple organ systems, wide range of disease, viral, premalignant and malignant tissue. Cryosurgical instrument used to necrose unwanted tissue in the gynecological and dermatological practice

Source page: https://510kreport.com/device/K110754
Methodology: https://510kreport.com/methodology