K173601 is an FDA 510(k) clearance for the Merit Syringe. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on January 31, 2018, 71 days after receiving the submission on November 21, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K173601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2017 |
| Decision Date | January 31, 2018 |
| Days to Decision | 71 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |