(102 days)
Polypectomy Snares are used for cutting of polyps.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called "Horizons Reusable Polypectomy Snares." This document is a regulatory approval and does not contain information about acceptance criteria, device performance studies, or details regarding AI algorithms.
Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence to a predicate device, not on clinical performance metrics or studies as typically described for AI device evaluations.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).