FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000
FDA 510(k) clearance K100947 · decided 2010-06-28
Clearance details
- K-number
- K100947
- Device name
- FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000
- Applicant
- Calibra Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-06
- Decision date
- 2010-06-28
- Days to decision
- 83 days
- Clearance type
- Special
- Product code
- OPP
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CeQur Simplicity™ On-Demand Insulin Delivery System (K252757) | Cequr SA | 2026-04-10 |
| CeQur Simplicity™ On-Demand Insulin Delivery System (K243273) | Cequr SA | 2024-11-13 |
| CeQur Simplicity™ On-Demand Insulin Delivery System (K233447) | Cequr SA | 2024-01-18 |
| OneTouch Via On-Demand Insulin Delivery System (K163357) | Lifescan Europe, A Division of Cilag GmbH | 2017-06-07 |
| FINESSE PERSONAL INSULIN DELIVERY PATCH (K111924) | Calibra Medical, Inc. | 2012-04-10 |
| FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 (K093065) | Calibra Medical, Inc. | 2010-01-20 |
Recalls involving this device
No recalls on record reference this clearance.