DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH TWO PIECE, SB 312RS, TWO DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH

K982884 · New Deantronics, Ltd. · GEI · Sep 14, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982884
• Device Name: DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH TWO PIECE, SB 312RS, TWO DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH
• Applicant: New Deantronics, Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Electrosurgical accessory. Hand switching, disposable pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.

Device Story

Disposable hand-switching electrosurgical pencil; rocker switch; two-piece design. Used by surgeons in clinical settings to deliver high-frequency electrical current for tissue cutting and coagulation. Device connects to electrosurgical generator; operator controls activation via hand-held rocker switch. Provides precise control over energy delivery during surgical procedures; facilitates hemostasis and tissue excision.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable electrosurgical pencil; rocker switch mechanism; two-piece construction. Operates as an accessory to high-frequency electrosurgical generators. No software or electronic processing components.

Indications for Use

Indicated for use as an electrosurgical accessory for tissue removal and hemostasis via high-frequency electrical current.

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 Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 1998

New Deantronics Taiwan, Ltd. c/o L.W. Ward and Associates, Inc. Mr. Lewis Ward 4655 Kirkwood Court Boulder, Colorado 80301

Re: K982884

Trade Name: Disposable Hand Switching Pencil, Rocker Switch Two Piece Regulatory Class: II Product Code: GEI Dated: July 31, 1998 Received: August 17, 1998

Dear Mr. Ward:

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 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). 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 requirements, 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.

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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 (301)-594-4639. 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/dsma/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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## K 982884 Initial 510(k)

Device Name: New Deantronics, Inc. Model SB 312 Disposable Hand Switching Pencil, Rocker Switch, two piece.

Indications for Use:

Electrosurgical accessory. Hand switching, disposable pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.

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Concurrence of DCRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR Over-the-Counter Use

(Division Sign Off)
Division of ral Restorative Devices
510(k) Number K982884