# K980393: Soprano Cryo-Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Gynecare Innovation Center
- Decided: May 1, 1998 after 88 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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) Frigitonics CCS 100: named in the summary without a submission number
- (no number) CMS AccuProbe: named in the summary without a submission number

## Indications for use
The Soprano™ Cryo-Therapy System is intended for use in the surgical ablation of tissue by the application of extreme cold in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, E.N.T., gynecology, oncology, proctology and urology.

Source page: https://510kreport.com/device/K980393
Methodology: https://510kreport.com/methodology