Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set
FDA 510(k) clearance K162812 · decided 2017-11-01
Clearance details
- K-number
- K162812
- Device name
- Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set
- Applicant
- Unomedical A/S
- Decision
- Substantially Equivalent
- Date received
- 2016-10-06
- Decision date
- 2017-11-01
- Days to decision
- 391 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Osted, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VariSoft Infusion Set, Single Use. recall (Z-3186-2024) | Unomedical A/S | 2024-09-19 |
| Neria Soft Infusion Set, Product Code 507302, intravascular administration set recall (Z-1544-2024) | Unomedical A/S | 2024-04-15 |
| VariSoft infusion set, Model Number 1002827 recall (Z-0232-2024) | Unomedical A/S | 2023-11-21 |
| VariSoft infusion set, Model Number 1002828 recall (Z-0233-2024) | Unomedical A/S | 2023-11-21 |
| VariSoft infusion set, Model Number 1002830 recall (Z-0234-2024) | Unomedical A/S | 2023-11-21 |