SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles— 510(k) K160316

Substantially Equivalent

M.D.L. S.R.L.

FDA 510(k) clearance K160316 for SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles, Substantially Equivalent on 2016-10-27. Applicant: M.D.L. S.R.L..

Clearance details

Applicant: M.D.L. S.R.L.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2016-02-05
Decision date: 2016-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Delebio (So), IT

Download summary PDF View on FDA.gov ↗

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, 2020-01-01 through 2026-04-23. 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.