K Number
K011236Device Name
MODIFICATION TO IMPLANTABLE CLIPManufacturer
Date Cleared
2001-05-14
(21 days)
Product Code
Regulation Number
878.4300Type
SpecialPanel
SUReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 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.