ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250— 510(k) K032545

Name: FDA 510(k) clearance K032545
Creator: U.S. Food and Drug Administration
Published: 2003-09-02

Substantially Equivalent

Mgb Endoskopische Gerate GmbH (Berlin)

FDA 510(k) clearance K032545 for ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250, Substantially Equivalent on 2003-09-02. Applicant: Mgb Endoskopische Gerate GmbH (Berlin). Device class: 2.

Clearance details

Applicant: Mgb Endoskopische Gerate GmbH (Berlin)
Product code: Code FET
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2003-08-18
Decision date: 2003-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berlin, DE

Download summary PDF View on FDA.gov ↗

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K092584 — LAPORT2010-03-22
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K032544 — VP-1000; MED CAM 100; VP-3000A; MED CAM 3002003-09-02

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.