# K163090: Plasma Edge System

- Pathway: 510(k) (Traditional)
- Applicant: Chirurgie Innovation
- Decided: May 23, 2017 after 200 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: 7 generations back to K911904 (1991). 23 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994166: Gyrus Endourology System: Axipolar Resectoscope Electrode, Gyrus Medical, Ltd. (1999) Summary page 4.
- K120567: Gyrus Amci PK Button Electrode, Gyrus Acmi, Inc. (2012) Summary page 4.

## Most influential descendants
- K213135: Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge (2022), 1 descendant of its own
- K240504: PLASMA EDGE System (2024), 0 descendants of its own

## 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 of urology. 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 hyperplasia * 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 hyperplasia, and for Transurethral Vaporization of bladder tumors. (MVVS and MVV models only)

Source page: https://510kreport.com/device/K163090
Methodology: https://510kreport.com/methodology