About This 510(k) Submission
K091968 is an FDA 510(k) clearance for the KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C, a Light Source, Fiberoptic, Routine (Class II — Special Controls, product code FCW), submitted by KARL STORZ Endoscopy-America, Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 14, 2009, 75 days after receiving the submission on July 1, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.