# K030194: Xues-41 Endoscopic Electrosurgical Unit

- Pathway: 510(k) (Traditional)
- Applicant: The Olympus Optical Co.
- Decided: Mar 24, 2003 after 62 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K911904 (1991). 9 ancestors in all.
49 later devices descend from it; 4 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023767: Ues-30 Electrosurgical Unit and It's Associated Accessories, The Olympus Optical Co. (2002) Summary page 3.
- K990628: Gyrus Endourology System, Gyrus Medical, Ltd. (1999) Summary page 3.

## Most influential descendants
- K100816: PK Superpulse Sysem Generator Model 744000 (2010), 22 descendants of its own
- K110268: Forcetriad Electrosurgical Generator (2011), 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
- K103032: Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W, Footswitch Single Pedal Model WB50403W, P-Cord Model Maj (2011), 12 descendants of its own
- K141225: Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-Cord (2014), 11 descendants of its own

## Recalls of this device
- Dec 27, 2011 · Not classified · Z-0829-2012: Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements
- Dec 27, 2011 · Not classified · Z-0828-2012: Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements
- Nov 10, 2009 · Class II · Z-1277-2013: Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. The upgrade and enhancement were initiated due to complaints of overheating, smoke vapors and failure to 

## Indications for use
This instrument has been designed for use in a medical facility under the supervision of a trained physician. It has been designed for general(open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes(fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery(cutting and coagulation), light sources and other ancillary equipment.

Source page: https://510kreport.com/device/K030194
Methodology: https://510kreport.com/methodology