# K063238: Ultraclip II Wing and Ultraclip II Coil

- Pathway: 510(k) (Traditional)
- Applicant: Inrad
- Decided: Jan 30, 2007 after 96 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
No predicates in its family tree.
4 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K090547: Ultraclip II US Wing and Coil, Models: 862017U, 864017U (2009), 3 descendants of its own
- 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

## Indications for use
The intended use of the Ultraclip IIWING and Ultraclip IICOIL is 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/K063238
Methodology: https://510kreport.com/methodology