# K973297: Cosman Coagulator (CC-1) System

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Oct 29, 1997 after 57 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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 CBC-1 Bipolar Coagulator: named in the summary without a submission number
- (no number) Codman Malis CMC-III: named in the summary without a submission number
- (no number) Valleylab Force 40 with Current Monitor: named in the summary without a submission number
- (no number) F.L. Fischer G50 Bipolator: named in the summary without a submission number
- (no number) Somnus Model 3000 Tri-Needle Electrode: named in the summary without a submission number
- (no number) Zomed Model 30-6 Multielectrode Array: named in the summary without a submission number

## Most influential descendants
- K070446: Cool-Tip Switching Controller, CTSW Control (2007), 2 descendants of its own
- K203150: Cool-tip RF Ablation System E Series (2022), 0 descendants of its own
- K192715: CRF Radiofrequency Ablation System (2020), 0 descendants of its own

## Recalls of this device
- Aug 1, 2012 · Class II · Z-2301-2012: Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP sing

## Indications for use
To coagulate tissue.

Source page: https://510kreport.com/device/K973297
Methodology: https://510kreport.com/methodology