K210478 is an FDA 510(k) clearance for the 8mm Monopolar Curved Scissors. This device is classified as a System, Surgical, Computer Controlled Instrument, Remanufactured (Class II - Special Controls, product code QSM).
Submitted by Iconocare Health (Scottsdale, US). The FDA issued a Cleared decision on September 30, 2022, 588 days after receiving the submission on February 19, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. As Intended With The Originally Cleared Instrument..
| 510(k) Number | K210478 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2021 |
| Decision Date | September 30, 2022 |
| Days to Decision | 588 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QSM - System, Surgical, Computer Controlled Instrument, Remanufactured |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | As Intended With The Originally Cleared Instrument. |