# K011575: 22MM Siteselect Breast Biopsy Device Model SSD022

- Pathway: 510(k) (Traditional)
- Applicant: Imagyn Surgical
- Decided: Aug 17, 2001 after 87 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: 3 generations back to K871390 (1987). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993936: 15MM Siteselect Breast Biopsy Device, 10 MM Siteselect Breast Biopsy Device, 5MM Siteselect Breast Biopsy Device, Imagyn Surgical (1999) Summary page 1.
- K972328: Percutaneous Breast Biopsy (PBB), Urothealth System, Inc. (1998) Summary page 1.
- K983296: Auto Suture Abbi System, United States Surgical, A Division of Tyco Healthc (1999) Summary page 1.

## Cited in the summary but kept off the family tree
- K954628: ABBI. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K040087: Rabbit (2004), 0 descendants of its own

## Indications for use
SiteSelect® is a disposable, single use diagnostic device used to obtain localized large core biopsies of breast tissue of a mammographic abnormality, identified by the placement of a needle/localization wire, which is suspect to be malignant. The SiteSelect device is intended to provide tissue for histological examination with partial or complete removal of imaged lesions. The scope of a histological abnormality is not able to be determined from its mammographic appearance. Therefore, it is essential that the tissue margins be examined for margin involvement and completeness of removal in cases where the tissue sample is not found to be benign. SiteSelect is to be used in conjunction with a stereotactic mammographic imaging system capable of determining position of lesion within breast tissue. This device is used in conjunction with the SiteSelect Instrument Accessories, which are mounted on a stereotactic table and used with a stereotactic mammographic imaging system.

Source page: https://510kreport.com/device/K011575
Methodology: https://510kreport.com/methodology