# K192715: CRF Radiofrequency Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Cambridge Interventional, LLC
- Decided: Jan 7, 2020 after 102 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
Longest line of descent: 7 generations back to K870028 (1987). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070446: Cool-Tip Switching Controller, CTSW Control, Valleylab,A Division of Tyco Healthcare Group LP (2007) Summary page 4.

## Indications for use
The CRF Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic and intraoperative coagulation and ablation of tissue.

Source page: https://510kreport.com/device/K192715
Methodology: https://510kreport.com/methodology