# K993936: 15MM Siteselect Breast Biopsy Device, 10 MM Siteselect Breast Biopsy Device, 5MM Siteselect Breast Biopsy Device

- Pathway: 510(k) (Traditional)
- Applicant: Imagyn Surgical
- Decided: Dec 27, 1999 after 38 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Imagyn Surgical SiteSelect devices: named in the summary without a submission number
- (no number) USSC ABBI device: named in the summary without a submission number

## Most influential descendants
- K011575: 22MM Siteselect Breast Biopsy Device Model SSD022 (2001), 1 descendant of its own
- K040087: Rabbit (2004), 0 descendants of its own
- K020024: Caris Minitome Biopsy Instrument (2002), 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 it's mammographic appearance. Therefore, it is essential that ihe 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 stereotactic mammographic imaging systems 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/K993936
Methodology: https://510kreport.com/methodology