K220057 is an FDA 510(k) clearance for the Disposable Sterile Syringe with permanently attached needle. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Shinva Ande Healthcare Apparatus Co., Ltd. (Zibo, CN). The FDA issued a Cleared decision on October 7, 2022, 274 days after receiving the submission on January 6, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K220057 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 2022 |
| Decision Date | October 07, 2022 |
| Days to Decision | 274 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 |