# K994166: Gyrus Endourology System: Axipolar Resectoscope Electrode

- Pathway: 510(k) (Special)
- Applicant: Gyrus Medical, Ltd.
- Decided: Dec 27, 1999 after 18 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: 2 generations back to K933002 (1994). 6 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990628: Gyrus Endourology System, Gyrus Medical, Ltd. (1999) Summary page 1.

## Most influential descendants
- K100275: Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection Electrode Loops and Bands (2010), 15 descendants of its own
- K152092: Resection Electrodes (2015), 5 descendants of its own
- K102781: Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode Rollers and Needles, Loops and Bands (2011), 5 descendants of its own
- K171965: Resection Electrodes with HF cable (2017), 3 descendants of its own
- K120567: Gyrus Amci PK Button Electrode (2012), 3 descendants of its own

## Indications for use
The Gyrus Endourology System, when used with a Gyrus “Axipolar Resectoscope Electrode, is a radio frequency bipolar electrosurgical device system intended for use in urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. The specific urological indications where the system can be used are in transurethral prostatectomy (TURP) for benign prostatic hypertrophy, transurethral incision of the prostate (TUIP) or bladder neck, resection of bladder tumors and in cystodiathermy.

Source page: https://510kreport.com/device/K994166
Methodology: https://510kreport.com/methodology