Concert Medical Hands-Free Syringe (HFS)— 510(k) K153599

Substantially Equivalent

Concert Medical, LLC

FDA 510(k) clearance K153599 for Concert Medical Hands-Free Syringe (HFS), Substantially Equivalent on 2016-09-01. Applicant: Concert Medical, LLC.

Clearance details

Applicant: Concert Medical, LLC
Product code: Code FRN
Advisory panel: General Hospital
Date received: 2015-12-16
Decision date: 2016-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwell, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.