K113587 is an FDA 510(k) clearance for the AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE). This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Shantou Wealy Medical Instrument Co.,Ltd (Echo, US). The FDA issued a Cleared decision on February 24, 2012, 81 days after receiving the submission on December 5, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K113587 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2011 |
| Decision Date | February 24, 2012 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| 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 |