# K230650: Monopolar Electrode Surgical Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Vhmed (Nantong) Co., Ltd.
- Decided: Oct 12, 2023 after 217 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 K932832 (1994). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142208: Monopolar Laparascopic Accessories, Unimicro Medical Systems (Shenzhen) Co., Ltd. (2015) Summary page 4.

## Indications for use
The device is a family of instruments which includes scissors, probes and forceps which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar Electrosurgical cutting and/or coagulation.

Source page: https://510kreport.com/device/K230650
Methodology: https://510kreport.com/methodology