NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/ HOLSTER, ES SMOKE & FLUID PENCIL W/ HOLSTER MODEL

K981614 · Aaron Medical Industries · GEI · Jul 17, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981614
• Device Name: NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/ HOLSTER, ES SMOKE & FLUID PENCIL W/ HOLSTER MODEL
• Applicant: Aaron Medical Industries
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The Aaron Electrosurgical Pencil Holster is supplied sterile, and is designed to hold an electrosurgical pencil in the operating room when not in use.

Device Story

The Aaron Electrosurgical Pencil Holster is a sterile, passive accessory designed for use in the operating room. It functions as a storage receptacle for electrosurgical pencils during periods of non-use. The device provides a designated, safe location for the pencil to prevent accidental activation or damage when not being utilized by the surgeon. It is a mechanical device with no electronic or software components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Sterile, passive mechanical holster for electrosurgical pencils. No energy source, software, or complex materials specified.

Indications for Use

Indicated for use in the operating room to hold electrosurgical pencils when not in active use.

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

JUL 1 7 1998

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

K981614 Re:

Trade Name: Aaron Electrosurgical Pencil Holster Regulatory Class: II Product Code: GEI Dated: May 5, 1998 Received: May 6, 1998

## Dear Mr. Saron:

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. J. Robert Saron

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,

Cella 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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x 9 81614 )(k) Number (if known):____

Aaron Electrosurgical Pencil Holster Device Name:

Indications For Use:

The Aaron Electrosurgical Pencil Holster is supplied sterile, and is designed to hold an electrosurgical pencil in the operating room when not in use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sian
Division of
510(k) Numbe

: K981614
es

Prescription Use
- 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)