K211484 is an FDA 510(k) clearance for the Disposable Sterile Syringe with Safety 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 March 1, 2022, 293 days after receiving the submission on May 12, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K211484 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2021 |
| Decision Date | March 01, 2022 |
| Days to Decision | 293 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 |