DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT HOLSTER, MODELS SB 312PB, SB 312 PBH

K982744 · New Deantronics Taiwan , Ltd. · GEI · Sep 11, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982744
• Device Name: DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT HOLSTER, MODELS SB 312PB, SB 312 PBH
• Applicant: New Deantronics Taiwan , Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 11, 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 the survey of the comments of and stricel overant Electrosurgicul accousery. Thanks of high-frequency electrical current.

Device Story

Disposable electrosurgical hand-switching pencil; push-button activation; two-piece body design; available with or without holster. Device functions as an accessory to electrosurgical generators to deliver high-frequency electrical current for cutting or coagulating tissue. Operated by surgeons or clinical staff in surgical settings. Provides manual control of electrical output via push-button interface. Benefits include disposable design to reduce cross-contamination risk and ergonomic hand-switching capability for precise control during procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable electrosurgical pencil; push-button switch mechanism; two-piece plastic body construction; compatible with standard electrosurgical generators for high-frequency current delivery.

Indications for Use

Indicated for use as an electrosurgical accessory for the delivery of high-frequency electrical current 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1 1998

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

Re: K982744

Trade Name: Model SB 312 PB and SB 32 PBH Disposable Hand Switching Pencil, Push Button, Two Piece Body, With and Without Holster Regulatory Class: II Product Code: GEI Dated: July 31, 1998 Received: August 6, 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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## Page 2 - Mr. Lewis Ward

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/dsma/dsmamain.html".

Sincerely yours,

J. Powell

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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Initial 510(k)

K982744

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

Indications for Use:

Electrosurgical accessory. Hand switching, disposable pencil intended to remove
t the survey of the comments of and stricel overant Electrosurgicul accousery. Thanks of high-frequency electrical current.

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

Concurrence of DCRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

X
OR Over-the-Counter Use

(Division Sign-Off)
Divi of General Restative Devices
510(k) Number K982744