# K024089: Vacuflash Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Bip USA, Inc.
- Decided: Mar 11, 2003 after 90 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: 1 generation back to K970565 (1997). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970565: Mammotome Biopsy Probe and Housing (Mammotome), Biopsys Medical, Inc. (1997)
- K991980: Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster and Cables, Software Package, Footswitch,, Ethicon Endo-Surgery, Inc. (1999) Summary page 2.
- K003297: Mammotome Hand Held Probe, Model MHH8, Ethicon Endo-Surgery, Inc. (2001) Summary page 2.
- K010400: Vacuum Assisted Core Biopsy Device, Promex, Inc. (2001) Summary page 2.

## Most influential descendants
- 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 BIP VacuFlash Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument is intended 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/K024089
Methodology: https://510kreport.com/methodology