K201619 is an FDA 510(k) clearance for the EndoTool IV System. This device is classified as a Calculator, Drug Dose (Class II - Special Controls, product code NDC).
Submitted by Monarch Medical Technologies, LLC (Charlotte, US). The FDA issued a Cleared decision on August 7, 2020, 53 days after receiving the submission on June 15, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K201619 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2020 |
| Decision Date | August 07, 2020 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NDC - Calculator, Drug Dose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |