(222 days)
Instrument for flexible endoscopy for grasping and removing tissue in the gastrointestinal tract.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Traction Polypectomy Snare." It indicates that the device has been found substantially equivalent to previously marketed devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about device performance metrics, sample sizes, expert qualifications, or ground truth establishment.
The document primarily focuses on regulatory aspects:
- Approval of the 510(k) premarket notification.
- Classification of the device (Class II, Product Code: FDI).
- Applicable regulations (21 CFR 876.4300 for Endoscopic electrosurgical unit and accessories).
- General controls provisions of the Act.
- Contact information for various FDA divisions.
- The "Indications for Use" statement for the device.
Therefore, I cannot provide the requested information based solely on the provided text. The prompt asks for details that are part of a performance study report or clinical trial summary, which are not present in this FDA clearance letter.
§ 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).