K213146 is an FDA 510(k) clearance for the Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen. This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).
Submitted by Jiangsu Rongye Technology Co., Ltd. (Jiangsu, CN). The FDA issued a Cleared decision on October 27, 2023, 760 days after receiving the submission on September 27, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K213146 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2021 |
| Decision Date | October 27, 2023 |
| Days to Decision | 760 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | JKA - Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |