# K042274: PSD-60/Endoplasma

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Shirakawa Co., Ltd.
- Decided: Feb 22, 2005 after 183 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: 4 generations back to K911904 (1991). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023886: Erbe Vio Esu with Accessories, Model Vio 300 D, Erbe USA, Inc. (2002) Summary page 2.
- K970184: Olympus Ues-20 Electrosurgical System and Its Associated Accessories, Olympus America, Inc. (1997) Summary page 2.
- K030194: Xues-41 Endoscopic Electrosurgical Unit, The Olympus Optical Co. (2003) Summary page 2.
- K024047: Erbe Vio Apc with Accessories, Erbe USA, Inc. (2003) Summary page 2.
- K963189: Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and Accessories, Erbe USA, Inc. (1996) Summary page 4.

## Indications for use
The PSD-60 has been designed to be used with OLYMPUS endoscope (fiberscope, videoscope and rigid scope) compatible with electrosurgical accessories and other ancillary equipment for general, laparoscopic and endoscopic electrosurgery (cutting, coagulation, including soft tissue coagulation). The argon plasma coagulation unit has been designed to be used with the electrosurgical unit, OLYMPUS PSD-60 for argon plasma coagulation (APC) of living tissues in treatment using OLYMPUS endoscope compatible with electrosurgery, argon plasma coagulation accessories and other ancillary equipment for endoscopic electrosurgery (coagulation).

Source page: https://510kreport.com/device/K042274
Methodology: https://510kreport.com/methodology