(79 days)
The Visu-Loc™ 5mm Clip Applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
Not Found
The provided text describes an FDA 510(k) clearance letter for the Visu-Loc™ 5mm Clip Applier. It acknowledges the device's substantial equivalence to legally marketed predicate devices and details the regulatory classification and general controls. However, it does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is a regulatory clearance letter, not a detailed study report.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.