K203566 is an FDA 510(k) clearance for the Tablet Application. This device is classified as a Endoscopic Central Control Unit (Class II - Special Controls, product code ODA).
Submitted by Smith & Nephew (Andover, US). The FDA issued a Cleared decision on May 13, 2021, 157 days after receiving the submission on December 7, 2020.
This device falls under the General & Plastic Surgery 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 | K203566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2020 |
| Decision Date | May 13, 2021 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| 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. |