M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem— 510(k) K161409

Substantially Equivalent

Mermaid Medical A/S

FDA 510(k) clearance K161409 for M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem, Substantially Equivalent on 2016-08-02. Applicant: Mermaid Medical A/S.

Clearance details

Applicant: Mermaid Medical A/S
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2016-05-20
Decision date: 2016-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stenloese, DK

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.