# K991792: Cryo-Mono Cryogenic System, Model Cryo-Mono with Tuf Probe

- Pathway: 510(k) (Traditional)
- Applicant: Influence, Inc.
- Decided: Aug 12, 1999 after 78 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Galil Medical, Ltd.’s Cryo-Hit Cryogenic System: named in the summary without a submission number
- (no number) Endocare’s CryoCare™ cryogenic system: named in the summary without a submission number
- (no number) Vidamed’s TUNA system: named in the summary without a submission number

## Indications for use
The Cryo-Mono Cryogenic System is intended for cryogenic destruction of tissues 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, including liver metastases, skin lesions, warts, and prostate tissues. Cryo-Mono with TUF probe is specifically indicated for the ablation of prostate tissue in cases of benign prostatic hyperplasia ("BPH").

Source page: https://510kreport.com/device/K991792
Methodology: https://510kreport.com/methodology