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Mammomark, Mammomark Mr and Cormark Biopsy Site Identifiers

by Ethicon Endo-Sugery, LLC

510(k) K082278

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK082278 Date16 Dec 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NEU
Device Class
Class II
Regulation
21 CFR Part 878.4300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Mammomark, Mammomark Mr and Cormark Biopsy Site Identifiers are implantable radiographic markers used to identify biopsy sites in breast tissue. These devices are designed to be placed at the site of a breast biopsy to mark the location for future reference, particularly in imaging follow-up.

They are supplied sterile and intended for single-use. The device is regulated under FDA 510(k) clearance K082278, classified as a Class II device under regulation number 878.4300, with medical specialty in General and Plastic Surgery. The markers are compatible with ultrasound, stereotactic, and MRI-guided biopsy procedures and expand in size within 60 seconds after deployment to reduce movement upon release of breast compression.

Other devices from Ethicon Endo-Sugery, LLC

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Mammomark Biopsy Site Identifier used for?

    The Mammomark, Mammomark Mr and Cormark Biopsy Site Identifiers are implantable radiographic markers designed to be placed at the site of a breast biopsy to mark the location for future reference, particularly in imaging follow-up procedures such as ultrasound, stereotactic, or MRI-guided biopsies.

  • How is the Mammomark device supplied and is it reusable?

    The device is supplied sterile and intended for single-use only; it is not designed or labeled for reuse, and reusing it could compromise sterility and functionality, posing risks to patient safety.

  • What happens to the Mammomark marker after deployment in breast tissue?

    After deployment, the marker expands in size within 60 seconds to reduce movement upon release of breast compression, helping ensure it remains fixed at the biopsy site for accurate long-term localization in follow-up imaging.