K214004 is an FDA 510(k) clearance for the CCBIO ASCPO Needle. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Cc Biotechnology Corporation (Tainan, TW). The FDA issued a Cleared decision on December 13, 2022, 357 days after receiving the submission on December 21, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K214004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2021 |
| Decision Date | December 13, 2022 |
| Days to Decision | 357 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 |