K191359 is an FDA 510(k) clearance for the Nipro Syringe. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on October 9, 2019, 141 days after receiving the submission on May 21, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K191359 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 2019 |
| Decision Date | October 09, 2019 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| 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 |