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Dune Medical Devices MarginProbe System

by Dilon Medical Technologies, Ltd. PMA

Active European Union and United States

PMA P110014

Overview

The Dune Medical Devices MarginProbe System is a diagnostic low electric field device designed to identify cancerous tissue at the margins of ex-vivo lumpectomy specimens. It serves as an adjunctive tool for use during breast lumpectomy surgery for patients with previously diagnosed breast cancer.

This system is intended for intraoperative use in conjunction with standard methods such as palpation and imaging to assess margins of 1mm or less. The device has received FDA PMA approval and meets MDD requirements for clinical use. It is designed to assist surgeons in evaluating the main lumpectomy specimen following primary excision.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP110014 Date27 Dec 2012ApprovedStatusActive
European UnionCE/MDD Number— Date—StatusNot known

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Not known
  • United States FDA PMA Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

PMA

Generic Name
Diagnostic low electric field
PMA Number
FDA Product Code
OEE
Device Class
Class III
Advisory Committee
General, Plastic Surgery
FDA Decision
APPR Approved

Other devices from Dilon Medical Technologies, Ltd.

Questions

  • What is the primary purpose of the MarginProbe System?

    The MarginProbe System is an adjunctive diagnostic tool used to identify cancerous tissue at the margins of an ex-vivo lumpectomy specimen, specifically targeting margins of 1mm or less.

  • When is the MarginProbe System used during surgery?

    The device is indicated for intraoperative use following the primary excision of the lumpectomy specimen in patients undergoing breast cancer surgery.

  • Does the MarginProbe System replace standard surgical methods?

    No, the system is designed to be used in conjunction with standard methods such as intraoperative imaging and palpation rather than replacing them.