K163511 is an FDA 510(k) clearance for the NovaGuard SA Pro Safety System. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by West Pharmaceutical Services, Inc. (Exton, US). The FDA issued a Cleared decision on February 2, 2017, 49 days after receiving the submission on December 15, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K163511 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2016 |
| Decision Date | February 02, 2017 |
| Days to Decision | 49 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEG - Syringe, Antistick |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |