# K233120: CWM-930S, Fixer DV9

- Pathway: 510(k) (Traditional)
- Applicant: Chungwoo Co., Ltd.
- Decided: May 23, 2024 after 239 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: 21 generations back to K943450 (1995). 287 ancestors in all.
No later device cites it as a predicate yet.
0 of 288 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210084: Silkro, Hironic Co., Ltd. (2022) Summary page 6.
- K193070: VIVACE Electrosurgical Device, ShenB Co., Ltd. (2021) Summary page 6.

## Indications for use
This device is intended for use in dermatologic and general surgical procedures for electro coagulation.

Source page: https://510kreport.com/device/K233120
Methodology: https://510kreport.com/methodology