SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200— 510(k) K912447

Name: FDA 510(k) clearance K912447
Creator: U.S. Food and Drug Administration
Published: 1991-09-27

Substantially Equivalent

Medical Laser, Inc.

FDA 510(k) clearance K912447 for SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200, Substantially Equivalent on 1991-09-27. Applicant: Medical Laser, Inc.. Device class: 2.

Clearance details

Applicant: Medical Laser, Inc.
Product code: Code FET
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1991-06-03
Decision date: 1991-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.