(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.
§ 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.