K222705 is an FDA 510(k) clearance for the Introducer Needle. This device is classified as a Catheter, Nephrostomy.
Submitted by Youcare Technology Co.,Ltd. (Wuhan) (Wuhan, CN). The FDA issued a Cleared decision on May 22, 2023, 257 days after receiving the submission on September 7, 2022.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K222705 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2022 |
| Decision Date | May 22, 2023 |
| Days to Decision | 257 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LJE - Catheter, Nephrostomy |
| Device Class | - |