This instrument has been designed for general and endoscopic electrosurgery including polypectomy, TUR, and laparoscopy (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light source, and ancillary equipment.

Device Description

AI/ML Overview

This document describes the UES-30 Electrosurgical Unit, a Class II medical device, for which a 510(k) premarket notification was submitted. The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory submission for premarket clearance and focuses on substantial equivalence to a predicate device.

Therefore, the requested information (points 1-9) cannot be extracted from the provided text as it is not present.

Summary

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NOV 2 9 2002

SMDA 510(k) SUMMARY

KO23767 UES-30 Electrosurgical Unit and its associated accessories

A. Submitter's Name, Address, Phone and Fax Numbers

Name & Address of manufacturer:	Olympus Optical Co., Ltd.34-3 Hirai Hinide-Machi, Nishitama-Gun ,Tokyo 190-00182, Japan
Registration No.:	3003637092
Address, Phone and Fax NumbersOf R&D Endoscope Division:	2951 Ishikawa-Cho, Hachioji-shi,Tokyo 192-8507,JapanTEL 81-426-42-2891FAX 81-426-46-5613

B. Name of Contact Person

Name:	Laura Storms-Tyler
Address, Phone and Fax Numbers:	Olympus America Inc.Two Corporate Center DriveMelville, New York 11747-3157TEL: (631) 844-5688FAX: (631) 844-5416

C. Device Name, Common Name, Classification Name and Predicate Devices

Trade Name:	UES-30 Electrosurgical Unit and its associated accessories
Common Name:	Electrosurgical Unit
Classification:	21 CFR 876.4300 Endoscopic electrosurgical unit and accessories,Class II21 CFR 878.4400 Electrosurgical cutting and coagulation device andaccessories, Class II
Predicate Device:	UES-20 (#K970184)

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D. Description of the Device(s)

E. Intended Use of the Device(s)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Public Health Service

NOV 2 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The Olympus Optical Company Laura Storms-Tyler Director, Regulatory Affairs and Quality Assurance Two Corporate Center Drive Melville, New York 11747-3157

Re: K023767

Trade/Device Name: UES-30 Electrosurgical Unit and its associated accessories Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 11, 2002 Received: November 12, 2002

Dear Ms. Storms-Tyler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the

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Page 2 -- Ms. Storms-Tyler

quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 5100k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

Muriam C. Provost

for Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

KO23767

Not assigned yet. 510(k) Number(if known):

Name: UES-30 Electrosurgical Unit and its associated Device accessories

Indications for Use: ·

This instrument has been designed for general and endoscopic electrosurgery including polypectomy, TUR, and laparoscopy (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, and rigid scopes) applicable to electrosurgery, light source and ancillary equipment.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

ાર

Over-The-Counter Use

(Prescription 21 CFR 801.109)

(Optional Format 1-2-96)

Misiam C. Provost

Avision Sign-Uit Division of General, Restorative nd Neurological Devices

K023767

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.