# K090547: Ultraclip II US Wing and Coil, Models: 862017U, 864017U

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 18, 2009 after 16 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K063238 (2007). 1 ancestor in all.
3 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)
- K063238: Ultraclip II Wing and Ultraclip II Coil, Inrad (2007) Summary page 1.

## Most influential descendants
- K152510: UltraCor Twirl Breast Tissue Marker (2016), 2 descendants of its own
- K180061: UltraCor Twirl Breast Tissue Marker (2018), 1 descendant of its own
- K243642: UltraCor™ Twirl™ Breast Tissue Marker (2025), 0 descendants of its own

## Recalls of this device
- Jan 23, 2013 · Class II · Z-1528-2013: Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distrib
- Jan 23, 2013 · Class II · Z-1527-2013: Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distrib
- Jan 23, 2013 · Class II · Z-1529-2013: Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distrib
- Jan 23, 2013 · Class II · Z-1526-2013: Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distrib

## Indications for use
The UltraClip IIUS Wing and Coil are 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/K090547
Methodology: https://510kreport.com/methodology