(78 days)
Instrument for flexible endoscopy, for full-thickness resection and diagnostic tissue acquisition through removal of suitable lesions in the stomach and duodenum.
The gastroduodenal FTRD is indicated for the resection of lesions
Not Found
The provided text is an FDA 510(k) clearance letter for the gastroduodenal FTRD Set. It does not contain information about acceptance criteria, device performance, study design, expert qualifications, or ground truth establishment.
The document describes the device's indications for use and lists general regulatory compliance requirements. It is a clearance letter, not a clinical study report or a summary of such a report.
Therefore, I cannot provide the requested information based on the input text.
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.