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UltraCor Twirl Breast Tissue Marker

by Bard Peripheral Vascular, Inc. 510(k)

Active United States

510(k) K152510

Overview

The UltraCor Twirl Breast Tissue Marker is a radiographic, implantable marker device. It is a nitinol, ring-shaped marker designed for visibility under ultrasound without the need for polymers or gels.

It is supplied as a single-use device with a 17-gauge, 10 cm rigid needle applicator. The device is intended for breast tissue marking and is authorized under FDA 510(k) clearance K152510.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK152510 Date13 May 2016ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

From the manufacturer

The Art Of Ultrasound Visibility Three-dimensional shapes designed to maximize visualization under ultrasound without the need for polymers and gels. The UltraCor™ Twirl™ Breast Tissue Marker presents a comprehensive shape and size offering for increased biopsy marking options.

Source: bd.com

The UltraCor™ Twirl™ Breast Tissue Marker consists of a nitinol, ring-shaped marker, designed and sized for usability. As the latest addition to the BD breast tissue marker portfolio, the UltraCor™ Twirl™ Breast Tissue Marker is available in a 17-gauge, 10 cm needle.

Source: go.bd.com

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Questions

  • What is the UltraCor Twirl Breast Tissue Marker used for?

    The UltraCor Twirl Breast Tissue Marker is intended for breast tissue marking, providing a radiographic, implantable marker that is visible under ultrasound without requiring polymers or gels for enhanced visibility during imaging procedures.

  • How is the UltraCor Twirl Breast Tissue Marker supplied and is it reusable?

    The device is supplied as a single-use device with a 17-gauge, 10 cm rigid needle applicator, meaning it is designed for one-time use only and should not be reprocessed or reused to ensure patient safety and device integrity.

  • What material is the UltraCor Twirl Breast Tissue Marker made of and what is its shape?

    The marker is made of nitinol and is ring-shaped, which allows for reliable ultrasound visibility and secure tissue implantation without the need for additional polymers or gels to enhance detection.