510(k) K243273
- Device
- CeQur Simplicity? On-Demand Insulin Delivery System
- Applicant
- Cequr SA
- 510(k) number
- K243273
- Product code
- OPP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-11-13
- Date received
- 2024-10-16
- Regulation
- 880.5725
- Classification name
- Pump, Infusion, Insulin Bolus
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Michael Simpson
- Address
- Ebenaustrasse 10 Horw Luzern CH 6048 6048
FDA Registration Numbers#
- 1721676
- 1000165286
- 2246552
- 3015218509
- 1047843
- 3007871880
Source Documents#
Other 510(k) Records For Product Code OPP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252757 | CeQur Simplicity™ On-Demand Insulin Delivery System | Cequr SA | 2026-04-10 |
| K233447 | CeQur Simplicity™ On-Demand Insulin Delivery System | Cequr SA | 2024-01-18 |
| K163357 | OneTouch Via On-Demand Insulin Delivery System | Lifescan Europe, A Division of Cilag GmbH | 2017-06-07 |
| K111924 | FINESSE PERSONAL INSULIN DELIVERY PATCH | Calibra Medical, Inc. | 2012-04-10 |
| K100947 | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 | Calibra Medical, Inc. | 2010-06-28 |
| K093065 | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 | Calibra Medical, Inc. | 2010-01-20 |