# K242907: DELPHI System

- Pathway: 510(k) (Traditional)
- Applicant: CnS Medical Co., Ltd.
- Decided: Jun 6, 2025 after 255 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: 8 generations back to K011083 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220563: Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System, ArthroCare Corporation (2022) Summary page 5.

## Indications for use
DELPHI System is indicated for coagulation and ablation of tissue and hemostasis of blood vessels during arthroscopic surgery. DELPHI System is designed for exclusive use with DELPHI PLUS or DISCORE bipolar electrode.

Source page: https://510kreport.com/device/K242907
Methodology: https://510kreport.com/methodology