K151282 is an FDA 510(k) clearance for the core nova Complete Operating Room Endoscopy, a Endoscopic Central Control Unit (Class II — Special Controls, product code ODA), submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on January 12, 2016, 243 days after receiving the submission on May 14, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K151282 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 14, 2015 |
| Decision Date | January 12, 2016 |
| Days to Decision | 243 days |
| Submission Type | Traditional |
| 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. |