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K Number
K042341
Device Name
ULTRACLIP II US
Manufacturer
INRAD
Date Cleared
2004-09-20

(21 days)

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

The Ultraclip II US intended use is to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy procedure.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) K042341 for the Inrad, Inc. Ultraclip® II US does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

This document is a letter from the FDA granting substantial equivalence to the Ultraclip® II US to a legally marketed predicate device. It identifies the device, its regulation number, and states that it can be marketed. It also includes an "INDICATIONS FOR USE STATEMENT" which describes the intended use of the device.

Therefore, I cannot provide the requested table and study details based on the given input.

§ 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.