K212635 is an FDA 510(k) clearance for the Sofjec. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Hwajin Medical Co., Ltd. (Cheonan-Si, KR). The FDA issued a Cleared decision on February 13, 2023, 543 days after receiving the submission on August 19, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K212635 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2021 |
| Decision Date | February 13, 2023 |
| Days to Decision | 543 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |