K212518 is an FDA 510(k) clearance for the Jeesung Safety Syringe and Single Use Needles. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Jeesung Medical Co., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on August 18, 2022, 373 days after receiving the submission on August 10, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K212518 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2021 |
| Decision Date | August 18, 2022 |
| Days to Decision | 373 days |
| Submission Type | Special |
| 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 |