ProSeal Bag Spike with Additive Port (423370ST, 423370)— 510(k) K251340

Substantially Equivalent

Epic Medical Pte. , Ltd.

FDA 510(k) clearance K251340 for ProSeal Bag Spike with Additive Port (423370ST, 423370), Substantially Equivalent on 2025-05-29. Applicant: Epic Medical Pte. , Ltd..

Clearance details

Applicant: Epic Medical Pte. , Ltd.
Product code: Code ONB
Advisory panel: General Hospital
Date received: 2025-04-30
Decision date: 2025-05-29
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.