New Medax Biopsy Systems— 510(k) K142125
Substantially EquivalentMedax Srl Unipersonale
FDA 510(k) clearance K142125 for New Medax Biopsy Systems, Substantially Equivalent on 2015-12-22. 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
- K172344 — Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)
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.