K230287 is an FDA 510(k) clearance for the SaviSafe Safety Device. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Suzhou Savicred Biotechnology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on November 21, 2023, 292 days after receiving the submission on February 2, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K230287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2023 |
| Decision Date | November 21, 2023 |
| Days to Decision | 292 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 |