Medline Catheter Specimen Collector— 510(k) K172541

Substantially Equivalent

Medline Industries, Inc.

FDA 510(k) clearance K172541 for Medline Catheter Specimen Collector, Substantially Equivalent on 2018-02-22. Applicant: Medline Industries, Inc..

Clearance details

Applicant: Medline Industries, Inc.
Product code: Code EZD
Advisory panel: Gastroenterology, Urology
Date received: 2017-08-23
Decision date: 2018-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northfiled, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

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.