K051613 is an FDA 510(k) clearance for the MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3. This device is classified as a Endoscopic Central Control Unit (Class II - Special Controls, product code ODA).
Submitted by Olympus Medical Systems Corporation (Melville, US). The FDA issued a Cleared decision on August 15, 2005, 59 days after receiving the submission on June 17, 2005.
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 | K051613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2005 |
| Decision Date | August 15, 2005 |
| Days to Decision | 59 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. |