DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
M.D.L. S.R.L.
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
Delebio (So), IT
Download summary PDFView on FDA.gov ↗

Recent devices under product code KNW

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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 →

Recalls naming K160316

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160316.

Data sourced from openFDA. This site is unofficial and independent of the FDA.