R2GATE Lite TM— 510(k) K223909

Name: FDA 510(k) clearance K223909
Creator: U.S. Food and Drug Administration
Published: 2023-10-20

Substantially Equivalent

Megagen Implant Co., Ltd.

FDA 510(k) clearance K223909 for R2GATE Lite TM, Substantially Equivalent on 2023-10-20. Applicant: Megagen Implant Co., Ltd.. Device class: 2.

Clearance details

Applicant: Megagen Implant Co., Ltd.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2022-12-29
Decision date: 2023-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deagu, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.