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HydroMARK Breast Biopsy Site Marker

FDA 510(k)

Class II (US FDA 510(k))

510(k) K212158

by Devicor Medical Products, Inc.

Identifiers

510(k) Number
K212158 FDA 510(k)
FDA Product Code
NEU FDA 510(k)

Classification

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

The HydroMARK Breast Biopsy Site Marker is a radiographic, implantable marker used to mark the site of a breast biopsy. It is classified as a Class II medical device under FDA regulation 878.4300 and has been determined to be substantially equivalent to a legally marketed predicate device.

The device is supplied sterile and intended for single-use application in breast biopsy procedures. It is compatible with ultrasound, stereotactic, and MRI-guided biopsy systems when used with appropriate applicators. Authorizations include FDA 510(k) clearance under K212158, and it is manufactured by Devicor Medical Products, Inc. in Cincinnati, Ohio.

Frequently asked questions

What is the HydroMARK Breast Biopsy Site Marker used for?

The HydroMARK Breast Biopsy Site Marker is used to mark the site of a breast biopsy procedure, allowing for future radiographic identification of the biopsy location in breast tissue.

How is the HydroMARK Breast Biopsy Site Marker supplied and is it reusable?

The device is supplied sterile and intended for single-use application only; it is not designed for cleaning, sterilization, or reuse after initial deployment in a biopsy procedure.

What imaging systems is the HydroMARK Breast Biopsy Site Marker compatible with?

The HydroMARK marker is compatible with ultrasound, stereotactic, and MRI-guided biopsy systems when used with appropriate applicators designed for each modality.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HydroMARK™ Breast Biopsy Site Markers | Mammotome, Mammotome® Markers Breast Biopsy Site Markers | Mammotome, HydroMARK™ Breast Biopsy Site Marker - Mammotome, MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC HYDROMARK ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Devicor Medical Products, Inc.

Sources (1)

  • FDA 510(k) K212158 24 fields · synced Sep 22, 2026