# K222542: MCB UNIT Model: V10GMCBUS

- Pathway: 510(k) (Traditional)
- Applicant: Lamidey Noury Medical
- Decided: Sep 21, 2022 after 30 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K911904 (1991). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100816: PK Superpulse Sysem Generator Model 744000, Gyrus Acmi, Inc. (2010) Summary page 4.

## Indications for use
Electrosurgical unit « MCB » is intended for use for the ablation, removal, resection, and coagulation of soft tissue, and where associated hemostasis is required in endoscopic urological surgical procedures. The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Source page: https://510kreport.com/device/K222542
Methodology: https://510kreport.com/methodology