K203566 is an FDA 510(k) clearance for the Tablet Application, 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 review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K203566 FDA.gov |
| FDA Decision | Cleared 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. |