# K972328: Percutaneous Breast Biopsy (PBB)

- Pathway: 510(k) (Traditional)
- Applicant: Urothealth System, Inc.
- Decided: Jul 7, 1998 after 379 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) United States Surgical Corporation (USSC) ABBI device: named in the summary without a submission number
- (no number) C.R. Bard device: named in the summary without a submission number
- (no number) Biopsys Medical device: named in the summary without a submission number
- (no number) USSC instrument holding devices: named in the summary without a submission number
- (no number) Biopsys instrument holding devices: named in the summary without a submission number
- (no number) C.R. Bard Magnum devices: 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

## Indications for use
Diagnostic device used to obtain localized biopsies within breast tissue. Device is for diagnostics purpose only, it is not for therapeutic use. To be used with Percutaneous Breast Biopsy Instrument Accessories (Instrument Holder, Needle Holder, and Stop), which are attached to a stereotactic table and used in conjunction with stereotactic mammographic imaging systems.

Source page: https://510kreport.com/device/K972328
Methodology: https://510kreport.com/methodology