eZSURE Empty Fluid Container (models 426030, 426040, 426110)— 510(k) K223674

Substantially Equivalent

Epic Medical Pte. , Ltd.

FDA 510(k) clearance K223674 for eZSURE Empty Fluid Container (models 426030, 426040, 426110), Substantially Equivalent on 2023-09-01. Applicant: Epic Medical Pte. , Ltd..

Clearance details

Applicant: Epic Medical Pte. , Ltd.
Product code: Code KPE
Advisory panel: General Hospital
Date received: 2022-12-07
Decision date: 2023-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.