Olympus PSD-20 Electrosurgical System and Accessories

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K970797 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• 3D Surgical Endoscopy System for General Surgery

  Class II

  FDA 510(k) K943307 Active Cleared 20 Dec 1995

• Olympus Fg-45/46-1 Grasping Forceps

  Class II

  FDA 510(k) K955049 Active Cleared 15 Dec 1995

• Olympus Unsaturated Iron Binding Capacity Reagent

  Class I

  FDA 510(k) K955139 Active Cleared 12 Feb 1996

• Olympus Fb Series Biopsy Forceps

  Class II

  FDA 510(k) K962555 Active Cleared 30 Jul 1996

• Olympus Fd-5 Hot Biopsy Forceps

  Class II

  FDA 510(k) K951445 Active Cleared 3 May 1995

• Olympus Biopsy Forceps Model Fb-44

  Class II

  FDA 510(k) K950786 Active Cleared 6 Mar 1995

See all devices from Olympus America, Inc. →

• What is the Olympus PSD-20 Electrosurgical System used for?

  The Olympus PSD-20 Electrosurgical System is used by trained physicians in medical facilities to cut and coagulate tissue during procedures. It serves as a power source for electrosurgical accessories such as snares and hot biopsy forceps when used with endoscopes, light sources, and ancillary equipment, delivering high-frequency electrical current to achieve tissue effects.

• How is the Olympus PSD-20 Electrosurgical System supplied and what does it include?

  The Olympus PSD-20 Electrosurgical System is supplied as a complete system that includes the electrosurgical unit and associated accessories. It is designed to work with compatible electrosurgical tools like snares and biopsy forceps, endoscopes (fiberscopes, videoscopes, rigid scopes), light sources, and other ancillary equipment required for endoscopic and surgical procedures.

• Is the Olympus PSD-20 Electrosurgical System intended for single-use or reuse?

  The Olympus PSD-20 Electrosurgical System itself is a reusable electrosurgical unit intended for multiple uses in medical facilities. However, the accessories it powers—such as snares and hot biopsy forceps—may be single-use or reusable depending on their design; the system description does not specify accessory sterility or reuse, so users must follow manufacturer guidelines for each accessory.

• What procedural settings is the Olympus PSD-20 Electrosurgical System indicated for?

  The Olympus PSD-20 Electrosurgical System is indicated for use in bronchial endoscopic procedures and general and plastic surgery settings, as determined by the advisory committee classification. It is intended for tissue cutting and coagulation in these clinical environments when used with compatible accessories and endoscopic equipment.