FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
CeQur Simplicity On-Demand Insulin Delivery System
K Number: K252757
·
Decision Apr 10, 2026
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
6
Applicant Total
3
Review Days
224
Basic Information
- Device Name
- CeQur Simplicity On-Demand Insulin Delivery System
- K Number
- K252757
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cequr SA
- Date Received
- August 29, 2025
- Decision Date
- April 10, 2026
- Product Code
- OPP
- Advisory Committee
- General Hospital
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OPP | Pump, Infusion, Insulin Bolus | FDA class 2 | General Hospital |
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