K190367 is an FDA 510(k) clearance for the Smith & Nephew Tablet Application. This device is classified as a Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera (Class II - Special Controls, product code QGY).
Submitted by Smith & Nephew (Andover, US). The FDA issued a Cleared decision on May 21, 2019, 95 days after receiving the submission on February 15, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. Device Is Intended For Wireless Control Of Settings For Surgical Or Endoscopic Camera Control Unit And Patient Information System..
| 510(k) Number | K190367 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2019 |
| Decision Date | May 21, 2019 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QGY - Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Device Is Intended For Wireless Control Of Settings For Surgical Or Endoscopic Camera Control Unit And Patient Information System. |