# K240504: PLASMA EDGE System

- Pathway: 510(k) (Special)
- Applicant: Lamidey Noury Medical
- Decided: Jun 12, 2024 after 112 days
- Product code: FAS (Electrode, Electrosurgical, Active, Urological)
- 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: 9 generations back to K911904 (1991). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213135: Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge, Chirurgie Innovation (2022) Summary page 5.

## Indications for use
The Plasma Edge System single use bipolar resection electrodes are used for the ablation and hemostasis of tissues under endoscopic control, in association with endoscopic accessories. They are intended for endoscopic surgeries with saline irrigation, in the field ofurology. The use of the Plasma Edge System is restricted to surgeons, specialized in urological surgery, for specific use in: * Transurethral resection of prostate (TURP) for benign prostatic hypertrophy * Transurethral incision of the prostate (TUIP) or bladder neck * Transurethral resection of bladder tumors (TURBT) * Cystodiathermy * Transurethral Vaporization of the prostate (TUVP/TVP) for benign prostatic hypertrophy, and for Transurethral Vaporization of bladder tumors. (MVVS models only)

Source page: https://510kreport.com/device/K240504
Methodology: https://510kreport.com/methodology