(78 days)
The Omnitech Resectoscope Cutting Loop Electrode Device is indicated for resection/ coagulation of the soft tissue and is intended for the use with compatible resection/ The device will be sold as a sterile product to be used in the Urological and Gynecological fields.
Omnitech Resectoscope Cutting Loop Electrode
I am sorry, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter for a "Resectoscope Cutting Loop Electrode" and primarily focuses on regulatory approval. It does not include details about device performance acceptance criteria, study methodologies, or AI/software validation.
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).