K243273 is an FDA 510(k) clearance for the CeQur Simplicity™ On-Demand Insulin Delivery System. This device is classified as a Pump, Infusion, Insulin Bolus (Class II - Special Controls, product code OPP).
Submitted by Cequr SA (Horw Luzern, CH). The FDA issued a Cleared decision on November 13, 2024, 28 days after receiving the submission on October 16, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 880.5725. The Device Is Adhered To The Body For Several Days For The Purpose Of Periodically Infusing An Insulin Bolus..
| 510(k) Number | K243273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 2024 |
| Decision Date | November 13, 2024 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | OPP - Pump, Infusion, Insulin Bolus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |
| Definition | The Device Is Adhered To The Body For Several Days For The Purpose Of Periodically Infusing An Insulin Bolus. |