# K201650: VMCore Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Uro-1, Inc.
- Decided: Jan 15, 2021 after 211 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 K092059 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092059: RP Cutting Needle, Riverpoint Medical (2009) Summary page 4.

## Indications for use
The VMCore biopsy needle is intended for use with the Bard Magnum reusable biopsy instrument for biopsies of soft tissues, such as the prostate, lung, kidney, or liver. The VMCore biopsy needle is not intended for use in bone

Source page: https://510kreport.com/device/K201650
Methodology: https://510kreport.com/methodology