K141245 is an FDA 510(k) clearance for the ETEX MIXING AND DELIVERY SYSTEM. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Etex Corporation (Cambridge, US). The FDA issued a Cleared decision on July 9, 2014, 56 days after receiving the submission on May 14, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K141245 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2014 |
| Decision Date | July 09, 2014 |
| Days to Decision | 56 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 |