The OnControl Bone Marrow Biopsy System by Vidacare— 510(k) K142377

Substantially Equivalent

Vidacare, LLC

FDA 510(k) clearance K142377 for The OnControl Bone Marrow Biopsy System by Vidacare, Substantially Equivalent on 2014-12-17. Applicant: Vidacare, LLC.

Clearance details

Applicant: Vidacare, LLC
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2014-08-26
Decision date: 2014-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shavano Park, TX, US

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.