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K Number
K050090
Device Name
GEL MARK V
Manufacturer
SENORX, INC.
Date Cleared
2005-02-07

(24 days)

Product Code
NEU
Regulation Number
878.4300
Type
Special
Panel
General & Plastic Surgery
Reference & Predicate Devices
K030090
Predicate For
K123911
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Gel Mark V is intended to radiographically and sonographically mark breast tissue during a percutaneous breast biopsy procedure.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for the 'Gel Mark V Biopsy Site Marker' as a substantially equivalent device. It does not contain the acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailed performance study results against specific criteria.

§ 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.