# K970797: Olympus PSD-20 Electrosurgical System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: May 28, 1997 after 85 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.
2 later devices descend from it; 2 cite it directly.
0 of 4 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
- K021852: Olympus PSD-20 Electrosurgical System & Its Associated Accessories (2003), 0 descendants of its own
- K023280: Olympus PSD-20 Electrosurgical System and Its Associated Accessories (2002), 0 descendants of its own

## Indications for use
The Olympus PSD-20 has been intended to cut and coagulate tissues within the gastrointestinal (GI) tract. The PSD-20 is designed to be used in conjunction with the electrosurgical accessories and the designated Olympus endoscopes that are applicable for electrosurgery. The Olympus PSD-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/K970797
Methodology: https://510kreport.com/methodology