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HydroMARK Biopsy Site Marker

by Biopsy Sciences, LLC

510(k) K060769

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 NumberK060769 Date25 Jul 2006ClearedStatusActive

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  • Withdrawn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, 22 Sep 2026

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

The HydroMARK Biopsy Site Marker is a water-containing, ultrasound-visible marker designed to mark tissue during a percutaneous breast biopsy procedure. It is intended to be visible under ultrasound and provides a non-metal marking alternative for biopsy site identification.

The device is supplied for single-use and is not MRI safe. It is authorized under FDA 510(k) clearance with product code NEU and is manufactured by Biopsy Sciences, LLC. The marker is available in various sizes and is designed to replace lengthy mammogram guided wire localization procedures with quicker, more comfortable ultrasound guided localization procedures.

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Questions

AI-generated answers, 22 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 HYDROMARK Biopsy Site Marker used for?

    The HYDROMARK Biopsy Site Marker is designed to mark tissue during percutaneous breast biopsy procedures. It provides a non-metal marking alternative that is visible under ultrasound, replacing lengthy mammogram guided wire localization with quicker, more comfortable ultrasound guided procedures.

  • How is the HYDROMARK Biopsy Site Marker supplied and is it reusable?

    The HYDROMARK Biopsy Site Marker is supplied for single-use only and is not intended for reuse. It is designed to be used once during a biopsy procedure and then discarded, ensuring sterility and preventing cross-contamination between patients.

  • What sizes and models of the HYDROMARK Biopsy Site Marker are available?

    The HYDROMARK Biopsy Site Marker is available in various sizes to accommodate different clinical needs. While specific size dimensions are not detailed in the provided information, the manufacturer offers multiple options to ensure appropriate selection for different biopsy procedures and patient anatomies.

  • Is the HYDROMARK Biopsy Site Marker MRI safe?

    No, the HYDROMARK Biopsy Site Marker is not MRI safe. This limitation should be considered when planning patient care and follow-up imaging procedures, particularly if MRI is anticipated as part of the diagnostic or monitoring process.

  • What regulatory authorization does the HYDROMARK Biopsy Site Marker have?

    The HYDROMARK Biopsy Site Marker is authorized under FDA 510(k) clearance with product code NEU. This regulatory pathway indicates that the device is substantially equivalent to legally marketed predicate devices, ensuring it meets the FDA's safety and effectiveness requirements for its intended use.