STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE

K974735 · Aaron Medical Industries · JOS · Jun 24, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K974735
• Device Name: STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE
• Applicant: Aaron Medical Industries
• Product Code: JOS · General, Plastic Surgery
• Decision Date: Jun 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Device is used for cutting and/or coagulation during open surgical procedures .

Device Story

Electrosurgical electrodes (Standard and Extended Blade, Needle, and Ball) used for cutting and coagulation during open surgical procedures. Device functions as a conductive tip for electrosurgical units; delivers high-frequency electrical current to tissue to achieve desired surgical effect. Operated by surgeons in clinical/OR settings. Benefits include precise tissue management during surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical electrodes (blade, needle, ball configurations). Conductive material construction. Designed for use with electrosurgical generators. Non-sterile or sterile (implied disposable).

Indications for Use

Indicated for cutting and/or coagulation during open 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 24 1998

Mr. J. Robert Saron ·President and CEO Aaron Medical Industries, Inc. 7100 30th Avenue North St. Petersburg, Florida 33710-2902

Re: K974735 Trade Name: Standard and Extended Blade, Needle and Ball Regulatory Class: II Product Code: GEI Dated: June 8, 1997 Received: June 10, 1997

## Dear Mr. Saron:

We have reviewed vour 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.

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.

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Page 2 - Mr. Saron

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) : K974735

_Realatick_II_(Disposable Electrosurgical Electrode) DEVICE NAME : INDICATIONS FOR USE:

> Device is used for cutting and/or coagulation during open surgical procedures .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use