ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL— 510(k) K080317

Substantially Equivalent

Syntheon, LLC

FDA 510(k) clearance K080317 for ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL, Substantially Equivalent on 2008-04-29. Applicant: Syntheon, LLC.

Clearance details

Applicant: Syntheon, LLC
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2008-02-06
Decision date: 2008-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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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.