ToxiSeal Vial Adaptor with External Flip Balloon— 510(k) K241476

Substantially Equivalent

Epic Medical Pte. , Ltd.

FDA 510(k) clearance K241476 for ToxiSeal Vial Adaptor with External Flip Balloon, Substantially Equivalent on 2024-06-21. Applicant: Epic Medical Pte. , Ltd..

Clearance details

Applicant: Epic Medical Pte. , Ltd.
Product code: Code ONB
Advisory panel: General Hospital
Date received: 2024-05-24
Decision date: 2024-06-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Singapore, SG

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.