# K970184: Olympus Ues-20 Electrosurgical System and Its Associated Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Apr 11, 1997 after 84 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K911904 (1991). 1 ancestor in all.
228 later devices descend from it; 4 cite it directly.
4 of 230 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911904: Models Ues-10 & PSD-10, Olympus Corp. (1991) Summary page 1.

## Most influential descendants
- K981993: Olympus Integrated Endosurgery System Endoalpha (1998), 175 descendants of its own
- K994231: Siemens Integrated Operating System (Sios) (2000), 157 descendants of its own
- K052202: Axiom Artis - Modular Angiographic System (2006), 154 descendants of its own
- K061054: Axiom Aristos FX Plus (2006), 80 descendants of its own
- K062623: Axiom Luminos DRF (2007), 78 descendants of its own

## Indications for use
The Olympus UES-20 has been designed for use in medical facilities under the supervision of a trained physician. It has been designed for general and endoscopic electrosurgery (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light sources and ancillary equipment. Do not use the instrument for any purpose other than its intended use.

Source page: https://510kreport.com/device/K970184
Methodology: https://510kreport.com/methodology