K133311 is an FDA 510(k) clearance for the ENDOLED. This device is classified as a Led Light Source (Class II - Special Controls, product code NTN).
Submitted by Olympus Winter & Ibe GmbH (Center Valley, US). The FDA issued a Cleared decision on July 30, 2014, 275 days after receiving the submission on October 28, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. Used To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals.
| 510(k) Number | K133311 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2013 |
| Decision Date | July 30, 2014 |
| Days to Decision | 275 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NTN — Led Light Source |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Used To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals |