(81 days)
The Microvascular Anastomotic COUPLER is to be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures.
The device is a sterile (gamma irradiation), single-use, implantable pair of rings molded out of high density polyethylene with six stainless steel pins on each of the ring. A probe-holder feature is molded on each of the paired rings to be a point of attachment for a sensor/probe at the site of anastomosis.
This document is a 510(k) premarket notification for the Microvascular Anastomotic Coupler and does not contain information regarding acceptance criteria or a study proving the device meets said criteria.
The document outlines the device's indications for use, technological comparison to a predicate device (GEM Microvascular Anastomotic Coupler; K861985), and asserts substantial equivalence in terms of biocompatibility, manufacturing, performance, sterilization, shelf life, packaging, safety, and efficacy to the predicate device.
Therefore, I cannot provide the requested information from the given text.
§ 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.