(14 days)
CONMED Stealth® Non-Stick Accessory Electrode is designed to fit all CONMED and most other electrosurgical pencils and chuck handles and intended for use in monopolar electrosurgical procedures for the dissection and coagulation of tissue. The electrode blade is to be a direct alternative to other electrode blades in distribution and will be made available in a variety of tip configurations for differing circumstances encountered during surgical procedures.
CONMED Stealth® Non-Stick Accessory Electrode is designed to fit all CONMED and most other electrosurgical pencils and chuck handles and intended for use in monopolar electrosurgical procedures for the dissection and coagulation of tissue. The electrode blade is to be a direct alternative to other electrode blades in distribution and will be made available in a variety of tip configurations for differing circumstances encountered during surgical procedures.
I am sorry. This document is a letter from the FDA regarding a 510(k) clearance for a medical device (ConMed Stealth® Non-Stick Accessory Electrode). It does not contain information about acceptance criteria, study details, or performance results. This type of information is typically found in the 510(k) summary or the full submission, which is not provided here.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 1999
Mr. Ira D. Duesler, Jr. Quality Engineer ConMed Corporation 310 Broad St. Utica, New York 13501
Re: K991855
Trade Name: ConMed Stealth® Non-Stick Accessory Electrode Regulatory Class: II Product Code: GEI Dated: May 28, 1999 Received: June 1, 1999
Dear Mr. Duesler:
We have reviewed your Section 510(k) notification of intent to market the device we nave loviewed your bothermined 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 Drug, and 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.
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Page 2 - Mr. Ira D. Duesler, Jr.
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 (301) 594-4659. 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
2
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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(Revised June 4, 1999) 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
CONMED Stealth® Non-Stick Accessory Electrode Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
CONMED Stealth® Non-Stick Accessory Electrode is designed to fit
ed to final and charactestesurgical nepcils and chuck handles and CONMED Steathy Non-Stick Accessory Licou onceller and chuck handles and
all CONMED and most other electrosurgical pencils and chuck handles and all CoNMED and most other electrosurgical procedures for the dissection
intended for use in monopolar electrosurgical procedures for the dissection intended for use in monopolar electrosurgical processes of its alternative to
and coagulation of tissue. The electrode blade is to be a direct alternative in a variety of and coagulation of tissue. The electrode blade is to be available in a variety of
other electrode blaces in distribution and will be made available in a variety of other electrode blades in distribution and will be museum.
tip configurations for differing circumstances encountered during surgical procedures.
(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 | K991855 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-the-Counter |
|---|---|---|
| --------------------------------------- | ---- | ------------------ |
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.