# K092338: Medax Unipersonale SRL

- Pathway: 510(k) (Traditional)
- Applicant: Medax Unipersonale Srl
- Decided: May 27, 2011 after 661 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. The FDA summary names no predicate by number.

## 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
Device name: Universal Duo. Intended use: to be used for histological biopsy on soft tissues. Device name: Neoxus. Intended use: to retrieve bone marrow and bone samples from iliac crest. Device name: Cage. Intended use: to retrieve bone marrow and bone samples from iliac crest. Device name: Velox. Intended use: histological biopsy on soft tissues Device name: Velox 2. Intended use: histolegical biopsy on soft tissues Device name: Universal Plus. Intended use: histological biopsy on soft tissues. Device name: Universal. Intended use: histological biopsy on soft tissues. Device name: Perfectus. Intended use: aspiration bone marrow from sternum or iliac crest. Device name: Lux. Intended use: histological biopsy on soft tissues Device name: Lux 2. Intended use: histological biopsy on soft tissues Device name: Hepax. Intended use: histological and cytological biopsies of soft tissue Device name: FNA (Chiba /Quincke /Turner/ Westcott / Franseen). Intended use: Aspiration needle for cyto - histological biopsies on soft tissue. Device name: Facile. Intended use: histological biopsy on soft tissues Device name: Cesar. Intended use: histological biopsy on soft tissues Device name: Nextage. Intended use: histological biopsy on soft tissues

Source page: https://510kreport.com/device/K092338
Methodology: https://510kreport.com/methodology