EDEN ControlCath— 510(k) K241410

Substantially Equivalent

Jmt Co., Ltd.

FDA 510(k) clearance K241410 for EDEN ControlCath, Substantially Equivalent on 2025-02-13. Applicant: Jmt Co., Ltd..

Clearance details

Applicant: Jmt Co., Ltd.
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 2024-05-17
Decision date: 2025-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yangju-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.