(306 days)
DTC Snare:
The DTC Snare is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for haemostasis or for treating lesions of the wall of gastrointestinal organs. Marking of lesions.
The clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of.
- Endoscopic marking
- Hemostasis for:
- Mucosal/submucosal defects
Not Found
The provided document is a 510(k) summary for a medical device called the "DTC Snare" and related instruments (Marking Probe, Grasper). It is a letter from the FDA determining substantial equivalence to a predicate device. This type of document indicates that the device has met the safety and effectiveness requirements of the predicate device, but it does not contain information about acceptance criteria or specific studies proving the device meets those criteria, nor does it typically include details about sample sizes, ground truth establishment, or expert involvement for a new study demonstrating performance.
Instead, this document confirms the device is substantially equivalent to a legally marketed predicate device based on its indications for use, technological characteristics, and safety and effectiveness information, which often involves comparing to published data or previous submissions for the predicate.
Therefore, I cannot provide the requested information from this document. The document primarily focuses on the regulatory clearance process rather than detailed performance study results of the DTC Snare itself.
§ 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.