ENDOGUIDE— 510(k) K063654

Name: FDA 510(k) clearance K063654
Creator: U.S. Food and Drug Administration
Published: 2007-01-31

Substantially Equivalent

Kms Medical, LLC

FDA 510(k) clearance K063654 for ENDOGUIDE, Substantially Equivalent on 2007-01-31. Applicant: Kms Medical, LLC. Device class: 2.

Clearance details

Applicant: Kms Medical, LLC
Product code: Code FDF
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2006-12-08
Decision date: 2007-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.