Dynarex Three-Way Stopcock— 510(k) K172266

Substantially Equivalent

Dynarex Corporation

FDA 510(k) clearance K172266 for Dynarex Three-Way Stopcock, Substantially Equivalent on 2018-03-14. Applicant: Dynarex Corporation.

Clearance details

Applicant: Dynarex Corporation
Product code: Code FMG
Advisory panel: General Hospital
Date received: 2017-07-27
Decision date: 2018-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMG

product code FMG

Death: 14
Malfunction: 3,433
Other: 1
Total: 3,448

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.