# K093068: Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk, F14105US

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 10, 2009 after 41 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: 2 generations back to K062832 (2006). 4 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082681: Vacora Vacuum Assisted Biopsy System, C.R. Bard, Inc. (2008) Summary page 2.
- K003297: Mammotome Hand Held Probe, Model MHH8, Ethicon Endo-Surgery, Inc. (2001) Summary page 2.
- K034021: Vacuum Assisted Core Biopsy Device, Suros Surgical Systems, Inc. (2004) Summary page 2.

## Most influential descendants
- K112411: Mammotome Elite Biopsy System (2012), 3 descendants of its own
- K153709: Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet,  Mammotome elite Biopsy System-10G Introducer Stylet (2016), 2 descendants of its own
- K103359: Finesse Ultra Breast Biopsy System Driver (Blue, Pink) (2010), 2 descendants of its own
- K192948: EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G (2019), 1 descendant of its own
- K220595: NeoNavia Biopsy System (2022), 0 descendants of its own

## Indications for use
The FINESSE TM Ultra Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis 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/K093068
Methodology: https://510kreport.com/methodology