FDA Product Code
FDA Product Code OPP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5725
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252757 | CeQur Simplicity On-Demand Insulin Delivery System | Cequr SA | 2026-04-10 | Special | PDF ↗ |
| K243273 | CeQur Simplicity On-Demand Insulin Delivery System | Cequr SA | 2024-11-13 | Special | PDF ↗ |
| K233447 | CeQur Simplicity On-Demand Insulin Delivery System | Cequr SA | 2024-01-18 | Special | PDF ↗ |
| K163357 | OneTouch Via On-Demand Insulin Delivery System | Lifescan Europe, A Division of Cilag GmbH | 2017-06-07 | Traditional | PDF ↗ |
| K111924 | FINESSE PERSONAL INSULIN DELIVERY PATCH | Calibra Medical, Inc. | 2012-04-10 | Traditional | PDF ↗ |
| K100947 | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 | Calibra Medical, Inc. | 2010-06-28 | Special | PDF ↗ |
| K093065 | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 | Calibra Medical, Inc. | 2010-01-20 | Traditional | PDF ↗ |
Product code OPP · Class II · General Hospital. Data: openFDA.