DISPOSABLE BI-POLAR CABLE

K023966 · Modern Medical Equipment Mfg., Ltd. · GEI · Feb 27, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023966
• Device Name: DISPOSABLE BI-POLAR CABLE
• Applicant: Modern Medical Equipment Mfg., Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Disposable Bi-polar cables are used in conjunction with electrosurgery Disposable Bi-polar cables are accessories to electrosurgical power for cauterizing during surgery.

Device Story

Disposable Bi-polar forceps cable; connects electrosurgical generator to bipolar forceps; facilitates delivery of electrosurgical energy for tissue cauterization during surgery. Used in clinical surgical settings by physicians/surgeons. Device serves as conductive interface; ensures power transmission from generator to surgical site. Benefits include disposable nature, reducing risk of cross-contamination associated with reusable cables.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Electrosurgical accessory cable; conductive material; disposable; designed for bipolar electrosurgical applications.

Indications for Use

Indicated for use as an accessory to electrosurgical power units for cauterizing tissue 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2003

Mr. Roger Strube Sales Manager E & M Engineering, Inc. P.O. Box 11349 1705 Dabney Road RICHMOND VA 23230 Re: K023966 Trade/Device Name: Disposable Bi-polar Forceps Cable Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: 79 GEI Dated: November 26, 2002 Received: November 29, 2002

Dear Mr. Strube:

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. Ilsting 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 (PMA), it may be subject to 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 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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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 one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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) you may obtain. 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Reference K 023966

Disposable Bipolar Cable

Indications For Use

Disposable Bi-polar cables are used in conjunction with electrosurgery Disposable Di polar cables are accase ectrosurgical power for cauterizing during surgery.

Prescription Use_

Nancy Broylon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Device K023966
510(k) Number_