NON-STICK ELECTRODE

K043036 · Modern Medical Equipment Mfg., Ltd. · GEI · May 6, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043036
• Device Name: NON-STICK ELECTRODE
• Applicant: Modern Medical Equipment Mfg., Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

It is an electrosurgical cutting and coagulating device intended to remove tissues and control bleeding by means of high frequency electrical current.

Device Story

Modern Medical Non Stick Electrode is an electrosurgical accessory used for tissue cutting and coagulation. Device delivers high-frequency electrical current to target tissue to achieve hemostasis and excision. Operated by surgeons or clinicians in clinical/surgical settings. Non-stick coating minimizes tissue adhesion during procedures. Output is controlled via standard electrosurgical generator interface. Benefits include reduced tissue trauma and improved surgical efficiency during cutting and coagulation tasks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical electrode with non-stick coating. Operates via high-frequency electrical current supplied by an external electrosurgical generator. Class II device (21 CFR 878.4400).

Indications for Use

Indicated for use as an electrosurgical cutting and coagulating device to remove tissues and control bleeding via high frequency electrical current in patients requiring surgical intervention.

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

MAY - 6 2005

Modern Medical Equipment MFG., Ltd. C/o Mr. Robert Stillman E & M Engineering Incorporated 1705 Dabney Road Richmond, Virginia 23230

Re: K043036

Trade/Device Name: Modern Medical Non Stick Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 23 , 2004 Received: April 12, 2005

Dear Mr. Stillman:

We have reviewed your Section 510(k) premarket notification of intent to market the device w 6 nave ro rowed your ve determined 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 encreated) 7 the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de nees mat have been that do not require approval of a premarket approval application (PMA). and Cosmetic fore, market the device, subject to the general controls provisions of the Act. The r ou may, are ex vrovisions 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 (PMA), it your doviee is elassified (disalated). Existing major regulations affecting your device it may of subject to saon af Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA oun or found in the announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r tease be advisou that I Drimination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must of any I ederal 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 El It i at 6077, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quinny by our of provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Robert Stillman

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will and w you to begin mating of substantial equivalence of your device to a legally premation notificate 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 If you desire specific aarroliance at [phone] . Also, please note the regulation entitled, Contact the Oriece of Collect of Colling to the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,


Miriam C. Provost, Ph.D. Acting 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

| Applicant: | Modern Medical Equipment Mfg. Ltd. |
|---------------|------------------------------------|
| 510(k) Number | Not assigned yet K043036 |
| Device Name: | Modern Medical Non Stick Electrode |

Indications For Use:

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It is an electrosurgical cutting and coagulating device intended to remove tissues and control bleeding by means of high frequency electrical current.

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Prescription Use V AND/OR Over-The-Counter Use (Part 21 CFR 807 sub-part C (Part 21 CFR 801 sub-part D)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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