# K970565: Mammotome Biopsy Probe and Housing (Mammotome)

- Pathway: 510(k) (Traditional)
- Applicant: Biopsys Medical, Inc.
- Decided: Mar 28, 1997 after 43 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.
7 later devices descend from it; 3 cite it directly.
0 of 8 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) Biopsys Medical Needle: named in the summary without a submission number

## Most influential descendants
- K024089: Vacuflash Biopsy System (2003), 4 descendants of its own
- K053151: Rubicor Magic Breast Biopsy Device (2005), 3 descendants of its own
- K071048: Rubicor Magic Breast Biopsy Device, Model 31537 (2007), 1 descendant of its own
- K173316: SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device (2018), 0 descendants of its own
- K133702: Presto Breast Biopsy Device (2014), 0 descendants of its own

## Indications for use
The BMI Mammotome is intended for diagnostic sampling of breast tissue during a biopsy procedure.

Source page: https://510kreport.com/device/K970565
Methodology: https://510kreport.com/methodology