510(k) K243095— Mammotome AutoCore Single Insertion Core Biopsy System

Substantially Equivalent

Devicor Medical Products, Inc.

Clearance details

Applicant: Devicor Medical Products, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2024-09-30
Decision date: 2024-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

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.