Cleared Traditional

ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5

K021717 · World of Medicine Lemke GmbH · Gastroenterology & Urology

Aug 2002

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K021717 is an FDA 510(k) clearance for the ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5, a Light Source, Endoscope, Xenon Arc (Class II — Special Controls, product code GCT), submitted by World of Medicine Lemke GmbH (Cambridge, US). The FDA issued a Cleared decision on August 20, 2002, 89 days after receiving the submission on May 23, 2002. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K021717 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 2002
Decision Date	August 20, 2002
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF