LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS

K030831 · Modern Medical Equipment Mfg., Ltd. · GEI · Jun 15, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K030831
• Device Name: LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS
• Applicant: Modern Medical Equipment Mfg., Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The instrument is used to cut and coagulate the selected tissue for Laparoscopic procedure.

Device Story

Laparoscopic instruments and electrode tips used for electrosurgical cutting and coagulation of tissue during laparoscopic surgery. Device functions as an accessory to electrosurgical units; delivers electrical energy to target tissue via electrode tips. Operated by surgeons in clinical/OR settings. Provides mechanical access and electrical interface for tissue management; facilitates hemostasis and tissue resection. Benefits include minimally invasive surgical access and controlled tissue interaction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical cutting and coagulation device; accessory to electrosurgical units. Class II, Product Code GEI. Regulation 21 CFR 878.4400.

Indications for Use

Indicated for use in laparoscopic procedures to cut and coagulate selected 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 5 2004

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

Re: K030831

Trade/Device Name: Laparoscopic Instruments and Electrode Tips 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 we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the entressary of the enactment date of the Medical Device Amendments, or to eonimer of they to ria) 2011-07-11 in accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, interest, mains of the Act include requirements for annual registration, listing of general controll proficturing 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 n your device to such additional controls. Existing major regulations affecting your device can may or sabject to back as a saceral Regulations, Title 21, Parts 800 to 898. In addition, I·DA 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 I that FDA has made a determination that your device complies with other requirements of the Act mar I Dr has made a and regulations administered by other Federal agencies. You must or any I odetar states and equirements, 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) 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 [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 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,

Muriam 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):

K030831

Device Name:

Indications for Use:

Laparoscopic Instruments and Electrode Tips

The instrument is used to cut and coagulate the

selected tissue for Laparoscopic procedure.

Prescription Use √

Over-The-Counter _____________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

or

PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost
(Division Sign-Off)

Division of General, Restorativ and Neurological Devices

510(k) Number_KO3083)