# K034021: Vacuum Assisted Core Biopsy Device

- Pathway: 510(k) (Traditional)
- Applicant: Suros Surgical Systems, Inc.
- Decided: Sep 8, 2004 after 259 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.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K093068: Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk, F14105US (2009), 7 descendants of its own
- 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

## Indications for use
To obtain percutaneous core biopsy samples from soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, lung, breast, and lymrph nodes. When used for breast biopsy, the product is for diagnosis only.

Source page: https://510kreport.com/device/K034021
Methodology: https://510kreport.com/methodology