K140194 is an FDA 510(k) clearance for the NAMIC RCS SYRINGE. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Navilyst Medical, Inc. (Marlborough, US). The FDA issued a Cleared decision on April 14, 2014, 77 days after receiving the submission on January 27, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K140194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2014 |
| Decision Date | April 14, 2014 |
| Days to Decision | 77 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 |