ELECTROSURGICAL UNIT

K981781 · Hill-Med, Inc. · GEI · Dec 4, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981781
• Device Name: ELECTROSURGICAL UNIT
• Applicant: Hill-Med, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hil-800M Phis Electrocoagurator and surgical procedures such as and coagulate (burn) the skin in and currers' and coagurate (burn) the timery and general surgery. Federal Law restricts the use of this device by or on the order of qualified physician only.

Device Story

HM-880DG Plus Electrocoagulator; electrosurgical device used for cutting and coagulating skin tissue. Operated by physicians in clinical or surgical settings. Device delivers electrical energy to tissue to achieve hemostasis or tissue division. Output controlled by physician to manage thermal effects on tissue. Benefits include precise tissue management during surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical unit; energy-based tissue cutting and coagulation. Device operates via electrical current delivery. No specific materials, software, or connectivity details provided.

Indications for Use

Indicated for cutting and coagulating skin tissue during surgical procedures, including general surgery. Restricted to use by or on the order of a qualified physician.

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

DEC 4 1998

Mr. Ernesto Ackerman President and Chief Executive Officer Hill-Med Corporation 7217 North West 46th Street Miami, Florida 33166

Re: K981781 Trade Name: HM-880DG Plus Electrocoagulator Regulatory Class: II Product Code: GEI Dated: September 17, 1998 Received: September 21, 1998

Dear Mr. Ackerman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Ernesto Ackerman

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K981781

HM-880DG Plus Electronagulator Device Name:

HI-880DG Plus Electrocoagulator unit is to be used in order to cut Indications For Use: Hil-800M Phis Electrocoagurator and surgical procedures such as
and coagulate (burn) the skin in and currers' and coagurate (burn) the timery and general surgery.

> Federal Law restricts the use of this device by or on the order of qualified physician only.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General Restorative Devices
510(k) Number K961701

Prescription Use
(Per 21 CFR 801.109)

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Over-Tive-Counter Use

(Optional Formal 1-7-96)