K211160 is an FDA 510(k) clearance for the EndoTool SubQ 2.1. 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 October 28, 2021, 192 days after receiving the submission on April 19, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K211160 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2021 |
| Decision Date | October 28, 2021 |
| Days to Decision | 192 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 |