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K Number
K010910
Device Name
MEDICON YASARGIL CLIP APPLYING FORCEPS
Manufacturer
MEDICON, E.G.
Date Cleared
2001-08-01

(128 days)

Product Code
HCI
Regulation Number
882.4175
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 882.4175 Aneurysm clip applier.

(a)
Identification. An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips.(b)
Classification. Class II (performance standards).