# K965182: RFG-3CF

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Mar 12, 1997 after 78 days
- Product code: GXD (Generator, Lesion, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 882.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
79 later devices descend from it; 3 cite it directly.
0 of 80 devices 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) Radionics RFG-3C Lesion Generator: named in the summary without a submission number
- (no number) Fischer Neuro N50 System: named in the summary without a submission number
- (no number) Leksell Neuro Generator, LNG 30-T: named in the summary without a submission number
- (no number) Grass Instruments' Stimulator Model S5 with Constant Current Unit, Accessory Model CCU1: named in the summary without a submission number

## Most influential descendants
- K021329: Rita System (2002), 76 descendants of its own
- K042216: Cool-Tip RF Ablation System (2004), 75 descendants of its own
- K052796: Cool-Tip RF Generator, Cool-Tip RF System Accessories (2006), 56 descendants of its own
- K053290: Cool-Tip RF Generator, Cool-Tip RF System Accessories (2006), 50 descendants of its own
- K072687: Valleylab Microwave Ablation Generator (2008), 42 descendants of its own

## Indications for use
To create lesions during neurosurgical lesion procedures.

Source page: https://510kreport.com/device/K965182
Methodology: https://510kreport.com/methodology