LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE

K032965 · Modern Medical Equipment Mfg., Ltd. · GEI · May 13, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K032965
• Device Name: LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE
• Applicant: Modern Medical Equipment Mfg., Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Be commonly used in Minimally Invasive Surgery for coagulation and cutting of tissue.

Device Story

Laparoscopic instrument, electrode, and cable system used in minimally invasive surgery. Device delivers electrosurgical energy to target tissue for cutting and coagulation. Operated by surgeons in clinical/OR settings. System connects to standard electrosurgical generators to facilitate tissue management during laparoscopic procedures. Benefits include precise tissue interaction and hemostasis during minimally invasive interventions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Electrosurgical instrument, electrode, and cable assembly. Designed for use with standard electrosurgical generators. Class II device (21 CFR 878.4400, Product Code GEI).

Indications for Use

Indicated for use in minimally invasive surgery for the coagulation and cutting of tissue.

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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

MAY 1 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Lou Senior Project Engineer Modern Medical Equipment Mfg. Ltd. 5F. Gold King Ind. Building 35 Tai Lin Pai Road Kwai Chung, Hong Kong

Re: K032965

Trade/Device Name: Laparoscopic Instrument, Electrode and Cable Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 9, 2004 Received: April 13, 2004

Dear Mr. Lou:

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 (sec above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may or sain 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 mcan that FDA has made a dctermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any x 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 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. David Lou

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will and w you'll ough finding of substantial equivalence of your device to a legally premaince notifications of caresults 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 it you desire of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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. IDirector 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

510(k) Number (if known): K032965

Device Name: Laparoscopic Instrument, electrode and cable

Indications For Use:

Be commonly used in Minimally Invasive Surgery for coagulation and cutting of tissue.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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