K241622 is an FDA 510(k) clearance for the Extended Reservoir. This device is classified as a Pump, Infusion, Insulin (Class II - Special Controls, product code LZG).
Submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on July 2, 2024, 27 days after receiving the submission on June 5, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K241622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2024 |
| Decision Date | July 02, 2024 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LZG — Pump, Infusion, Insulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |