AARON COOLPAD SPLIT W/O CORD,AARON COOLPAD SPLIT WITH CORD, AARON COOLPAD W/O CORD, ARRON COOLPAD WITH CORD, MODELS ESRE
Device Facts
| Record ID | K983788 |
|---|---|
| Device Name | AARON COOLPAD SPLIT W/O CORD,AARON COOLPAD SPLIT WITH CORD, AARON COOLPAD W/O CORD, ARRON COOLPAD WITH CORD, MODELS ESRE |
| Applicant | Aaron Medical Industries |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Nov 25, 1998 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
Intended Use
This device is intended to be used in general electrosurgical procedures to provide a return path for the electrosurgical circuit between the patient and the electrosurgical generator.
Device Story
Aaron Coolpad is a patient return electrode (grounding pad) used in electrosurgical procedures. It functions as a conductive interface to complete the electrical circuit between the patient and an electrosurgical generator. The device is applied to the patient's skin to safely disperse high-frequency electrical current, preventing thermal injury at the contact site. It is intended for use in clinical settings, such as operating rooms, by healthcare professionals. The device is available in versions with or without a pre-attached cord.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Electrosurgical return electrode (grounding pad). Conductive material interface for electrical circuit completion. Available in corded and non-corded configurations. Class II device (Product Code: GEI).
Indications for Use
Indicated for use in general electrosurgical procedures as a patient return electrode to complete the electrosurgical circuit.
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.
Related Devices
- K984276 — DISPOSABLE ELECTROSURGERY GROUNDING PAD · E & M Engineering, Inc. · Feb 10, 1999
- K132136 — SINGLE USE GROUNDING PAD · Lccs Products Limited · Sep 6, 2013
- K030362 — SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES · Leonhard Lang GmbH · Apr 14, 2003
- K960569 — DISPOSABLE PATIENT RETURN ELECTRODE · Erbe USA, Inc. · Mar 11, 1996
- K983782 — ELECTROSURGICAL DISPERSIVE ELECTRODE · Conmedcorp · Jan 25, 1999
Submission Summary (Full Text)
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 5 1998
J. Robert Saron President & CEO Aaron Medical Industries 7100 30th Avenue North St. Petersburg, Florida 33710-2902
Re: K983788
Trade Name: Aaron Coolpad Split w/o Cord, Aaron Coolpad with cord Regulatory Class: II Product Code: GEI Dated: October 26, 1998 Received: October 27, 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 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 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 vour 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 (301) 594-4595. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
signature
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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Page 1 of
510(k) Number (if known):
Device Name:_Aaron_Coo1Pad
Indications For Use:
This device is intended to be used in general electrosurgical inis device is intended of be electrosurgical circuit between the patient and the electrosurgical generator.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K983788 |
Prescription Use (Per 21 CFR 801 109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
