K131226 is an FDA 510(k) clearance for the NOVAPROBE LED LIGHT SOURCE, a Light Source, Fiberoptic, Routine (Class II — Special Controls, product code FCW), submitted by Novaprobe Incorporated (Lansdale, US). The FDA issued a Cleared decision on July 24, 2014, 450 days after receiving the submission on April 30, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K131226 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 30, 2013 |
| Decision Date | July 24, 2014 |
| Days to Decision | 450 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCW — Light Source, Fiberoptic, Routine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |