K091968 is an FDA 510(k) clearance for the KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C. This device is classified as a Light Source, Fiberoptic, Routine (Class II - Special Controls, product code FCW).
Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, 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 FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K091968 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2009 |
| Decision Date | September 14, 2009 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FCW — Light Source, Fiberoptic, Routine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |