K162812 is an FDA 510(k) clearance for the 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. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Unomedical A/S (Osted, DK). The FDA issued a Cleared decision on November 1, 2017, 391 days after receiving the submission on October 6, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K162812 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 2016 |
| Decision Date | November 01, 2017 |
| Days to Decision | 391 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA - Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |