# K990628: Gyrus Endourology System

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Medical, Ltd.
- Decided: Jun 29, 1999 after 124 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: 1 generation back to K933002 (1994). 5 ancestors in all.
52 later devices descend from it; 4 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962482: Scuba System, Gynecare, Inc. (1996) Summary page 1.
- K982738: Versapoint Electrosurgery System (Scuba), Gynecare, Inc. (1999). Cleared while this submission was under review Summary page 1.
- K982771: Gyrus Hysteroscopic Resectoscope, Gyrus Medical, Ltd. (1999) Summary page 1.
- K933002: Erbotom Icc 350, Erbe USA, Inc. (1994) Summary page 1.
- K971881: Comeg Resectoscope and Laser-Resectoscope Working Elements/Urethrotomes/Electrodes/Albarrab Deflectors, Comeg Endoscopy (1997) Summary page 1.

## Most influential descendants
- K030194: Xues-41 Endoscopic Electrosurgical Unit (2003), 49 descendants of its own
- K100816: PK Superpulse Sysem Generator Model 744000 (2010), 22 descendants of its own
- K110268: Forcetriad Electrosurgical Generator (2011), 16 descendants of its own
- K994166: Gyrus Endourology System: Axipolar Resectoscope Electrode (1999), 16 descendants of its own
- K100275: Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection Electrode Loops and Bands (2010), 15 descendants of its own

## Indications for use
The Gyrus Endourology System 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/K990628
Methodology: https://510kreport.com/methodology