K202646 is an FDA 510(k) clearance for the Visera Elite II Video System Center. This device is classified as a Endoscopic Video Imaging System/component, Gastroenterology-urology (Class II - Special Controls, product code FET).
Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on October 29, 2020, 48 days after receiving the submission on September 11, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 876.1500. To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor..
| 510(k) Number | K202646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2020 |
| Decision Date | October 29, 2020 |
| Days to Decision | 48 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | FET — Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor. |