# K152510: UltraCor Twirl Breast Tissue Marker

- Pathway: 510(k) (Traditional)
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: May 13, 2016 after 254 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K063238 (2007). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090547: Ultraclip II US Wing and Coil, Models: 862017U, 864017U, C.R. Bard, Inc. (2009) Summary page 4.

## Most influential descendants
- K180061: UltraCor Twirl Breast Tissue Marker (2018), 1 descendant of its own
- K243642: UltraCor™ Twirl™ Breast Tissue Marker (2025), 0 descendants of its own

## Indications for use
The UltraCor Twirl Breast Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.

Source page: https://510kreport.com/device/K152510
Methodology: https://510kreport.com/methodology