K142636 is an FDA 510(k) clearance for the Merit 10mL 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 October 17, 2014, 30 days after receiving the submission on September 17, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K142636 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2014 |
| Decision Date | October 17, 2014 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |