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Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue Marker

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131654

by Senorx, Inc.

Identifiers

510(k) Number
K131654 FDA 510(k)
FDA Product Code
NEU FDA 510(k)
Models / Variants
Starchmark Breast Tissue Marker FDA 510(k)
Starchmark Ultracor Breast Tissue Marker 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 device is a radiographic marker, implantable, used to mark breast tissue during a percutaneous breast biopsy procedure. It uses polysaccharide (starch) pellets to help in the control and management of bleeding.

The device is sterile and single-use. It features a rigid needle applicator with a 14G beveled tip for visualization during deployment under ultrasound. It is authorized under FDA 510(k) clearance K131654.

Frequently asked questions

What is the STARCHMARK Breast Tissue Marker used for?

The STARCHMARK Breast Tissue Marker is used to mark breast tissue during a percutaneous breast biopsy procedure. It helps in the control and management of bleeding by deploying polysaccharide (starch) pellets at the biopsy site, providing a visible radiographic marker for future reference.

How is the STARCHMARK Breast Tissue Marker supplied and is it sterile?

The device is supplied sterile and is intended for single-use only. It features a rigid needle applicators that are sterilized and packaged for immediate use in clinical settings, ensuring no reprocessing is required or recommended.

What type of needle applicator does the STARCHMARK Breast Tissue Marker use?

The device features a rigid needle applicator with a 14G beveled tip. This design allows for clear visualization during deployment under ultrasound guidance, aiding accurate placement of the marker during percutaneous breast biopsy procedures.

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: StarchMark™ UltraCor™ Breast Tissue Marker - BD, StarchMark™ UltraCor™ Breast Tissue Marker - BD, Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue ..., Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Senorx, Inc.

Sources (1)

  • FDA 510(k) K131654 24 fields · synced Sep 21, 2026