HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K253761 FDA 510(k)
- FDA Product Code
- NEU FDA 510(k)
- Models / Variants
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)
This device is a Radiographic, Implantable Marker designed to permanently mark the location of breast biopsy sites. The HydroMARK Plus features two distinct shapes—Dragonfly and Hummingbird—each consisting of a two-component system for precise identification on mammographic imaging. Its primary function is to aid in the localization of biopsy cavities, ensuring accurate follow-up imaging and reducing the risk of misplacement or displacement during subsequent procedures.
The HydroMARK Plus is supplied as a sterile, single-use device intended for implantation during breast biopsy procedures. It is compatible with various biopsy devices, including those used for ultrasound-guided, stereotactic, and MRI-guided interventions. The marker is classified as Device Class II under FDA regulations and holds an FDA 510(k) clearance for substantial equivalence. Storage and handling follow standard sterile medical device protocols, with no MRI safety restrictions specified.
Frequently asked questions
What is the HydroMARK Plus Breast Biopsy Site Marker used for?
The HydroMARK Plus is designed to permanently mark the location of breast biopsy sites during mammographic imaging. Its two distinct shapes—Dragonfly and Hummingbird—help clinicians accurately identify biopsy cavities on follow-up imaging, reducing the risk of misplacement or displacement during subsequent procedures. This ensures precise localization for future diagnostic or therapeutic interventions.
How is the HydroMARK Plus supplied and what are its sterility and reuse details?
The HydroMARK Plus is supplied as a sterile, single-use device, meaning each marker is intended for one-time implantation during a breast biopsy procedure. Sterility is maintained through standard medical device packaging protocols, and reuse is not recommended to prevent contamination or compromise of imaging accuracy. Always follow sterile handling procedures as outlined in the device instructions.
Are there different sizes or models available for the HydroMARK Plus?
The HydroMARK Plus comes in two distinct shapes—Dragonfly and Hummingbird—but does not vary in size between these models. Both shapes are part of a two-component system designed for precise radiographic identification. The marker’s design ensures visibility on mammograms without altering its primary function or compatibility with biopsy devices.
How should the HydroMARK Plus be stored, and are there any MRI safety restrictions?
Storage follows standard sterile medical device protocols, including protection from moisture, extreme temperatures, and physical damage. The device packaging must remain intact until use. There are no specified MRI safety restrictions for the HydroMARK Plus, meaning it can be safely used in MRI-guided biopsy procedures without interference. Always verify compatibility with your specific MRI system and follow manufacturer guidelines.
What regulatory approvals does the HydroMARK Plus hold, and how does this affect its use?
The HydroMARK Plus holds FDA 510(k) clearance, indicating it is classified as substantially equivalent to a legally marketed predicate device under FDA regulations. This clearance confirms its safety and effectiveness for its intended use as a radiographic, implantable marker for breast biopsy sites. Clinicians and facilities should ensure compliance with FDA guidelines and institutional protocols when using the device.
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™ Plus Breast Biopsy Site Marker | Mammotome, HydroMARK™ Breast Biopsy Site Markers | Mammotome, HydroMARK™ Plus - Mammotome, HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253761 | Class II | Active |
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Manufacturer
- Manufacturer
- Devicor Medical Products, Inc.
Sources (1)
- FDA 510(k) K253761 24 fields · synced Oct 1, 2026