K131641 is an FDA 510(k) clearance for the MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP). 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 August 28, 2013, 85 days after receiving the submission on June 4, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K131641 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2013 |
| Decision Date | August 28, 2013 |
| Days to Decision | 85 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 |