K213077 is an FDA 510(k) clearance for the Automatically Retractable Safety Syringe. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Zhejiang Lingyang Medical Apparatus Co., Ltd. (Linhai, CN). The FDA issued a Cleared decision on April 27, 2022, 216 days after receiving the submission on September 23, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K213077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2021 |
| Decision Date | April 27, 2022 |
| Days to Decision | 216 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | MEG - Syringe, Antistick |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |