K122416 is an FDA 510(k) clearance for the ARTIGLASS L. O.R. GLASS SYRINGE. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Artiglass Srl (Due Carrare Padova, IT). The FDA issued a Cleared decision on May 3, 2013, 268 days after receiving the submission on August 8, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K122416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2012 |
| Decision Date | May 03, 2013 |
| Days to Decision | 268 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 |