Olympus UES-20 Electrosurgical System and Accessories

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

Full name

Olympus Ues-20 Electrosurgical System and Its Associated Accessories

510(k) Number

K970184 ↗

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 UES-20 Electrosurgical System used for?

  The Olympus UES-20 Electrosurgical System is designed to provide controlled electrosurgical energy for both cutting and coagulation during surgical procedures. It supports general and endoscopic applications, allowing precise tissue manipulation under physician supervision. This makes it suitable for open and endoscopic surgeries in medical facilities, aligning with FDA classifications for general and plastic surgery electrosurgical tools.

• Is the Olympus UES-20 Electrosurgical System reusable or single-use?

  The Olympus UES-20 Electrosurgical System is supplied as a reusable device. It requires proper maintenance and adherence to manufacturer guidelines to ensure safe and effective operation. Reusability is common for electrosurgical systems to balance cost efficiency and sterility protocols in clinical settings.

• What accessories are compatible with the Olympus UES-20?

  The UES-20 system is intended for use with designated Olympus accessories, including fiberscopes, videoscopes, and rigid scopes. These accessories enhance the system’s functionality by enabling precise tissue manipulation during surgical procedures. Always verify compatibility with the manufacturer’s specifications to ensure optimal performance.

• How should the Olympus UES-20 Electrosurgical System be stored?

  Storage and handling of the Olympus UES-20 must comply with regulatory and manufacturer guidelines to maintain sterility and functionality. While specific sterility claims are not detailed in the data, general electrosurgical systems require clean, dry environments away from direct sunlight or extreme temperatures. Follow Olympus’s instructions for cleaning, maintenance, and storage to ensure longevity and safety.

• What regulatory pathway was followed for the Olympus UES-20?

  The Olympus UES-20 Electrosurgical System received FDA clearance through the traditional review pathway, specifically under the 510(k) premarket notification process. It was determined to be substantially equivalent to a predicate device and holds clearance number K970184, with a decision date of April 11, 1997. This classification reflects its compliance with FDA regulations for electrosurgical cutting and coagulation devices.