K100345 is an FDA 510(k) clearance for the SYSTEMS INTEGRATION MODEL: ENDOALPHA. This device is classified as a Endoscopic Central Control Unit (Class II - Special Controls, product code ODA).
Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on March 22, 2010, 45 days after receiving the submission on February 5, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Control Endoscopic And Other Ancillary Surgical Equipment In One Central Location, Either By Remote Control, Touch Screen, Or Voice Command..
| 510(k) Number | K100345 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2010 |
| Decision Date | March 22, 2010 |
| Days to Decision | 45 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ODA — Endoscopic Central Control Unit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Control Endoscopic And Other Ancillary Surgical Equipment In One Central Location, Either By Remote Control, Touch Screen, Or Voice Command. |