# K220595: NeoNavia Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Neodynamics AB
- Decided: Sep 8, 2022 after 191 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: 5 generations back to K062832 (2006). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Devicor Medical Products, Inc. (2016) Summary page 4.

## Indications for use
The NeoNavia biopsy system is intended for obtaining tissue samples from both breast lesions and axillary lymph nodes for diagnostic analysis of breast abnormalities. The FlexiPulse and VacuPulse probes are intended to provide tissue from breast lesions and axillary lymph nodes for histologic examination. The NeoNavia biopsy system is to be used only by healthcare professionals in hospitals or healthcare facilities.

Source page: https://510kreport.com/device/K220595
Methodology: https://510kreport.com/methodology