K210748 is an FDA 510(k) clearance for the Well-life TM Pen Needles, Well-life TM Safety Pen Needles. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by W. L. Med Co., Ltd. (Anseong-Si, KR). The FDA issued a Cleared decision on May 25, 2022, 439 days after receiving the submission on March 12, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K210748 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2021 |
| Decision Date | May 25, 2022 |
| Days to Decision | 439 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMI - Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |