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K Number
K172479
Device Name
Amsel Occluder Device
Manufacturer
Amsel Medical
Date Cleared
2017-09-14

(29 days)

Product Code
FZP
Regulation Number
878.4300
Type
Special
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Amsel Occluder Device is intended for use in open general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter for the Amsel Occluder Device. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory clearance letter, not a clinical or performance study report.

Therefore, I cannot provide the requested information. The sections of your request that relate to acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies are not present in this document.

§ 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.