K233447 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 January 18, 2024, 91 days after receiving the submission on October 19, 2023.
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 | K233447 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2023 |
| Decision Date | January 18, 2024 |
| Days to Decision | 91 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. |