Equashield Closed System Transfer Device— 510(k) K221513

Substantially Equivalent

Equashield Medical , Ltd.

FDA 510(k) clearance K221513 for Equashield Closed System Transfer Device, Substantially Equivalent on 2023-02-17. Applicant: Equashield Medical , Ltd..

Clearance details

Applicant: Equashield Medical , Ltd.
Product code: Code ONB
Advisory panel: General Hospital
Date received: 2022-05-25
Decision date: 2023-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Migdal Tefen, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code ONB

product code ONB

Malfunction: 3,615
Other: 13
Total: 3,628

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.