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K Number
K003958
Device Name
COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE
Manufacturer
COALESCENT SURGICAL
Date Cleared
2001-02-06

(47 days)

Product Code
FZP
Regulation Number
878.4300
Type
Traditional
Panel
SU
Reference & Predicate Devices
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.