K141640 is an FDA 510(k) clearance for the AUTOMATICALLY RETRACTABLE SAFETY SYRINGES 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 (Lafayette, US). The FDA issued a Cleared decision on November 19, 2014, 153 days after receiving the submission on June 19, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K141640 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2014 |
| Decision Date | November 19, 2014 |
| Days to Decision | 153 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 |