# K023280: Olympus PSD-20 Electrosurgical System and Its Associated Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical Co., Ltd.
- Decided: Dec 19, 2002 after 79 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: 2 generations back to K911904 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970797: Olympus PSD-20 Electrosurgical System and Accessories, Olympus America, Inc. (1997) Summary page 1.
- K970184: Olympus Ues-20 Electrosurgical System and Its Associated Accessories, Olympus America, Inc. (1997) Summary page 1.

## Indications for use
This instrument has been designed to be used with Olympus recommended Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment for flexible cystoscopic treatment (cutting and coagulating) including: - Hemostasis of superficial bleeding - Treatment of bladder tumors - Treatment of stenosis inside urinary tract.

Source page: https://510kreport.com/device/K023280
Methodology: https://510kreport.com/methodology