# K040087: Rabbit

- Pathway: 510(k) (Traditional)
- Applicant: Scion International, Inc.
- Decided: Apr 1, 2004 after 76 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K871390 (1987). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983296: Auto Suture Abbi System, United States Surgical, A Division of Tyco Healthc (1999) Summary page 1.
- K011575: 22MM Siteselect Breast Biopsy Device Model SSD022, Imagyn Surgical (2001) Summary page 1.
- K003297: Mammotome Hand Held Probe, Model MHH8, Ethicon Endo-Surgery, Inc. (2001) Summary page 1.

## Indications for use
The Rabbit is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Source page: https://510kreport.com/device/K040087
Methodology: https://510kreport.com/methodology