# K991122: Cryo-Mono Cryogrnic System

- Pathway: 510(k) (Traditional)
- Applicant: Influence, Inc.
- Decided: Jul 1, 1999 after 90 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) Cryo-Hit Cryogenic 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, proctocology, and urology for the ablation of tissue, including liver metastases, skin lesions, warts, tonsils, turbinate reduction and prostate tissues. Cryo-Mono is specifically indicated for tonsil reduction in patients with blood dyscrasias or other bleeding problems and/or patients for whom general anesthesia presents an increased risk.

Source page: https://510kreport.com/device/K991122
Methodology: https://510kreport.com/methodology