# K142125: New Medax Biopsy Systems

- Pathway: 510(k) (Traditional)
- Applicant: Medax Srl Unipersonale
- Decided: Dec 22, 2015 after 505 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K172344: Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) (2017), 1 descendant of its own
- K192099: MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System (2020), 0 descendants of its own

## Indications for use
BIOFEATHER: biopsy system must be used for histological biopsy on soft tissue. AVANGARDE: biopsy system must to be used for histological biopsy on soft tissues. COX: the Co-Axial introducer needle mod. COX must be used when multiple biopsies of soft tissue are required.

Source page: https://510kreport.com/device/K142125
Methodology: https://510kreport.com/methodology