Medline Quick Switch Valve with ENFit Connector— 510(k) K191759

Substantially Equivalent

Medline Industries, Inc.

FDA 510(k) clearance K191759 for Medline Quick Switch Valve with ENFit Connector, Substantially Equivalent on 2019-12-04. Applicant: Medline Industries, Inc..

Clearance details

Applicant: Medline Industries, Inc.
Product code: Code PIF
Advisory panel: Gastroenterology, Urology
Date received: 2019-07-01
Decision date: 2019-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northfiled, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PIF

product code PIF

Death: 13
Injury: 122
Other: 1
Total: 136

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.