K160860 is an FDA 510(k) clearance for the MiniMed Quick-serter. This device is classified as a Introducer, Syringe Needle (Class II - Special Controls, product code KZH).
Submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on September 22, 2016, 177 days after receiving the submission on March 29, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6920.
| 510(k) Number | K160860 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2016 |
| Decision Date | September 22, 2016 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KZH — Introducer, Syringe Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6920 |