EM-9000— 510(k) K101482

Name: FDA 510(k) clearance K101482
Creator: U.S. Food and Drug Administration
Published: 2011-03-31

Substantially Equivalent

Elite Medical, Inc.

FDA 510(k) clearance K101482 for EM-9000, Substantially Equivalent on 2011-03-31. Applicant: Elite Medical, Inc.. Device class: 2.

Clearance details

Applicant: Elite Medical, Inc.
Product code: Code LNS
Device class: Class 2
Regulation: 21 CFR 876.5990
Advisory panel: Gastroenterology, Urology
Date received: 2010-05-28
Decision date: 2011-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LNS

product code LNS

Death: 4
Injury: 320
Total: 324

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.