(27 days)
The Ultraclip II MR intended use is to attach to soft breast tissue at the time of an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called Ultraclip® II MR. It does not contain the detailed study information, acceptance criteria, or performance data of the device.
Therefore, I cannot provide the requested information, which typically would be found in the manufacturer's submission or a separate scientific publication. This letter only confirms that the device has received market clearance based on substantial equivalence to a predicate device.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.