Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)— 510(k) K172344
Substantially EquivalentMedax Srl Unipersonale
FDA 510(k) clearance K172344 for Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK), Substantially Equivalent on 2017-11-13. Applicant: Medax Srl Unipersonale. Device class: 2.
Clearance details
- Applicant
- Medax Srl Unipersonale
- Product code
- Code KNW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Poggio Rusco, IT
Recent devices under product code KNW
view allMore clearances from Medax Srl Unipersonale
view all- 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
- K192101 — Medone Ultra, Medextra
- K181803 — Medax Biopsy Systems III
- K142125 — New Medax Biopsy Systems
Adverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.