# K021852: Olympus PSD-20 Electrosurgical System & Its Associated Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical Co., Ltd.
- Decided: Feb 11, 2003 after 251 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
This instrument has been designed to be used with Olympus recommended Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment for bronchial endoscopic treatment (cutting and coagulating) including; Hemostasis of superficial bleeding Treatment of benign tumors like papillomatosis, granulomas, polyps, lipomas and hemangiomas in the trachea and bronchi Recanalization of malignant stenoses Treatment of Cicatricial stenoses of the respiratory tract

Source page: https://510kreport.com/device/K021852
Methodology: https://510kreport.com/methodology