(40 days)
Horizon ligating clips are indicated for procedures involving vessels or anatomic structures where I iorizon ligating this are the best clip size, type and material based upon experience, judgement and needs.
Not Found
The provided document is an FDA 510(k) clearance letter for the Horizon Ligation Clips, dated August 10, 1998. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information about acceptance criteria, device performance, results of a study, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested information based on the input document. The document is primarily a regulatory approval letter and does not include the detailed technical study information that would be necessary to answer your questions.
§ 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.