MODERN MEDICAL BIPOLAR FORCEPS

K032327 · Modern Medical Equipment Mfg., Ltd. · GEI · Jun 15, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K032327
• Device Name: MODERN MEDICAL BIPOLAR FORCEPS
• 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

Intended to facilitate tissue grasping and control the bleeding of small vessel by bipolar coagulation

Device Story

Reusable bipolar forceps; used for tissue grasping and hemostasis via bipolar coagulation of small vessels. Device connects to electrosurgical generator; delivers high-frequency electrical current between two forceps tips to coagulate tissue. Operated by surgeons in clinical/OR settings. Provides mechanical grasping and electrical coagulation; aids in bleeding control during surgery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Reusable bipolar forceps; electrosurgical accessory. Operates via bipolar coagulation principle. Class II device (21 CFR 878.4400).

Indications for Use

Indicated for tissue grasping and bipolar coagulation of small vessels during surgical procedures.

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: K032327

Trade/Device Name: Reusable Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 29, 2004 Received: April 1, 2004

Dear Mr. Lou:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt 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 encreased of the enactment date of the Medical Device Amendments, or 10 commerce provide to they 20, 1978, in accordance with the provisions of the Federal Food, Drug, de vices that have been receive approval of a premarket approval application (PMA). allu Cosmette Act (110) that to hovice, subject to the general controls provisions of the Act. The r ou may, merchero, mains of the Act include requirements for annual registration, listing of general controls provisions 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 is clusion of or a croy of als. Existing major regulations affecting your device can thay be subject to sach additions, 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 r lease oc advised that I Dris issualite complies with other requirements of the Act that I DA has made a aoninistered by other Federal agencies. You must of any I edetal stututes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic (200 form in the quality of events (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 his letter will anow you to oegin matically of substantial equivalence of your device to a legally premarket nothication. The FDA midnig of backandar equal evice 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 if you desire specific advice for your act [phone]. Also, please note the regulation entitled, comact the Office of Complance at (301) of Crise Part 807.97). You may obtain Missianumy by reference to premainter.commibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Schess 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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## Indication for Use Statement KO32327

Modern Medical Equipment Mfg. Ltd. Applicant:

Not assigned yet 510(k) Number

Reusable bipolar forceps Device Name:

Indications For Use: Intended to facilitate tissue grasping and control the bleeding of small vessel by bipolar coagulation

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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

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Miriam C. Provost

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________