CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-6120

K020135 · Conmedcorp · GEI · Apr 12, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020135
• Device Name: CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-6120
• Applicant: Conmedcorp
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of a RF (radio frequency) electrosurgical current through an accessory electrode for . cutting and coagulation at the operative site.

Device Story

Conmed System 2000 ESU is a general-purpose electrosurgical generator. It functions by delivering radio frequency (RF) electrical current to an accessory handpiece and electrode. The device is operated by surgeons or clinical staff in an operative setting to perform tissue cutting and coagulation. The output is controlled by the user to achieve desired surgical effects, facilitating hemostasis and tissue dissection during procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical generator; RF energy source; intended for use with accessory handpieces and electrodes; standard electrosurgical output circuitry for cutting and coagulation.

Indications for Use

Indicated for use as a general-purpose electrosurgical generator for cutting and coagulation of tissue at the operative site in surgical procedures requiring RF electrosurgical current.

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.

Submission Summary (Full Text)

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Food and Drug Administration & S 9200 Corporate Boulevard Rockville MD 20850

## APR 1 2 2002

Conmed Corporation Mr. Charles M. Hart Director, RA/QA/Safety Conmed Electrosurgery 14603 Fremont Avenue Centennial, Colorado 80112

Re: K020135

Trade Name: Conmed System 2000 ESU Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 12, 2002 Received: January 15, 2002

Dear Mr. Hart:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your seemers er ermined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have May 28, 1970, the chance with the provisions of the Federal Food, Drug, and Cosmetic Act bect reclassified in accesapproval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, manier and the Act include requirements for annual registration, listing of devices, condons provisions or use ice, 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 If your device 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 orth in the 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.

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Page 2 - Mr. Charles Hart

This letter will allow you to begin marketing your device as described in your Section 510(k) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _____CONMED SYSTEM 2000 ESU

Indications for Use:

General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of a RF (radio frequency) electrosurgical current through an accessory electrode for . cutting and coagulation at the operative site.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C Proost

(Division Sign-Off) Division of General, Restorative and Neurological De ices

Prescription Use (Per 21 CFR 801.109)

2020135 510(k) Number -OR-

Over-The-Counter _____________________________________________________________________________________________________________________________________________________________