# K192101: Medone Ultra, Medextra

- Pathway: 510(k) (Traditional)
- Applicant: Medax Srl Unipersonale
- Decided: Apr 2, 2020 after 241 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: 3 generations back to K922939 (1993). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141552: Achieve Programmable Auomated Biopsy Systems, Care Fusion (2014) Summary page 5.
- K181803: Medax Biopsy Systems III, Medax Srl Unipersonale (2018) Summary page 5.

## Most influential descendants
- K210946: Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles (2021), 1 descendant of its own
- K261196: Promisemed VeriEcto Automatic Biopsy Needles (2026), 0 descendants of its own

## Indications for use
MEDONE ULTRA Soft tissue programmable automatic biopsy system: biopsy system has been designed to be used for histological biopsy of soft tissues (such as breast, kidney, liver, prostate and various soft tissue masses). It is not intended for use in bone biopsy. MEDEXTRA lymph node biopsy system with rectangular shaped cannula and adjustable penetration depth: is intended for use in obtaining biopsies from lymph nodes and other superficial non-vascular lumps. It is not intended for use in bone, deep visceral structures and breast biopsy.

Source page: https://510kreport.com/device/K192101
Methodology: https://510kreport.com/methodology