ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5— 510(k) K021717

Substantially Equivalent

World of Medicine Lemke GmbH

FDA 510(k) clearance K021717 for ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5, Substantially Equivalent on 2002-08-20. Applicant: World of Medicine Lemke GmbH.

Clearance details

Applicant: World of Medicine Lemke GmbH
Product code: Code GCT
Advisory panel: Gastroenterology, Urology
Date received: 2002-05-23
Decision date: 2002-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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Adverse events under product code GCT

product code GCT

Malfunction: 1,393
Other: 2
Total: 1,395

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.