OLYMPUS UES-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES

K970184 · Olympus America, Inc. · GEI · Apr 11, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970184
• Device Name: OLYMPUS UES-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
• Applicant: Olympus America, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Olympus UES-20 has been designed for use in medical facilities under the supervision of a trained physician. It has been designed for general and endoscopic electrosurgery (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light sources and ancillary equipment. Do not use the instrument for any purpose other than its intended use.

Device Story

Electrosurgical unit for cutting and coagulation; used in general and endoscopic surgery. Operates with Olympus-designated accessories, endoscopes, and light sources. Used in medical facilities by trained physicians. Provides high-frequency electrical energy to tissue via compatible accessories. Enables precise tissue management during endoscopic or open surgical procedures; enhances surgical efficiency and hemostasis.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Electrosurgical unit; high-frequency energy output for cutting and coagulation. Compatible with Olympus endoscopes and accessories. Class II device per 21 CFR 878.440 and 876.4300.

Indications for Use

Indicated for general and endoscopic electrosurgical cutting and coagulation procedures in medical facilities under physician supervision.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Olympus UES-10 Electrosurgical Unit (K911904)

Submission Summary (Full Text)

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K970184
APR 11 1997

# 510 (k) SUMMARY
## OLYMPUS UES-20 ELECTROSURGICAL SYSTEM

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section 807.92.

| **Device Name:** | Olympus UES-20 Electrosurgical System and its associated accessories. |
| --- | --- |
| **Common/Usual Name:** | Electrosurgical Units |
| **Classification Name:** | 21 CFR 878.440, Class II
Electrosurgical Cutting and Coagulation Device and Accessories. |
| | 21 CFR 876.4300, Class II
Endoscopic Electrosurgical Unit and Accessories. |
| **Predicate Devices:** | Olympus UES-10 Electrosurgical Unit (K911904) |
| **Prepared & Submitted By: (Contact Person)** | Mr. Subhash Patel
Olympus America Inc.
Endoscope Division
Two Corporate Center Drive
Melville, New York 11747-3157
[phone] |
| **Summary Preparation Date:** | January 15, 1997 |

## Statement of Intended Use:

### UES-20 Electrosurgical Unit

The Olympus UES-20 has been designed for use in medical facilities under the supervision of a trained physician. It has been designed for general and endoscopic electrosurgery (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light sources and ancillary equipment. Do not use the instrument for any purpose other than its intended use.

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