ELMED ESU 120 M/M DIGITAL

K974793 · Elmed, Inc. · GEI · Mar 19, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K974793
• Device Name: ELMED ESU 120 M/M DIGITAL
• Applicant: Elmed, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EIMED ESU 120 M/M DIGITAL is a electrosurgical system designed for surgical procedures to be chosen by licensed surgeons. The unit can be used for unipolar cutting, unipolar micro-coagulation and bimlar coagulation.

Device Story

Electrosurgical system for surgical procedures; operated by licensed surgeons in clinical settings. Device provides unipolar cutting, unipolar micro-coagulation, and bipolar coagulation capabilities. System functions as an electrosurgical unit (ESU) to deliver high-frequency electrical energy to tissue for cutting or coagulation. Output is controlled by the surgeon to achieve desired surgical effect. Benefits include precise tissue management during surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical unit (ESU) providing unipolar and bipolar output modes. Digital control interface. Device operates via high-frequency electrical energy for tissue cutting and coagulation.

Indications for Use

Indicated for use by licensed surgeons for surgical procedures requiring unipolar cutting, unipolar micro-coagulation, and bipolar coagulation.

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 9200 Corporate Boulevard Rockville MD 20850

MAR 19 1998

Mr. Werner Hausner Elmed Incorporated 60 West Fay Avenue 60101-5106 Addison, Illinois

K974793 Re: Elmed ESU 120 M/M Digital Trade Name: Requlatory Class: II Product Code: GEI December 18, 1997 Dated: Received: December 22, 1997

Dear Mr. Hausner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined 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 been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS)_for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. Hausner

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Stephen Rhodes

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

Enclosure

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510(k) Number (if known): K974793

Device Name:_ELMED ESU 120 M/M DIGITAL

Indications For Use:

The EIMED ESU 120 M/M DIGITAL is a electrosurgical system designed for surgical procedures to be chosen by licensed surgeons. The unit can be used for unipolar cutting, unipolar micro-coagulation and bimlar coagulation.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Stephen Rhodes

6974793

Prescription Use X (Per 21 CFR 801.109)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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