LogoFDA 510(k) Search
K Number
K011402
Device Name
BIOPSY SITE MARKER
Manufacturer
SENORX, INC.
Date Cleared
2001-07-16

(70 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.