K210516 is an FDA 510(k) clearance for the Clicky Cross. This device is classified as a Stopcock, I.v. Set (Class II - Special Controls, product code FMG).
Submitted by Yomura Technologies, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on May 16, 2022, 447 days after receiving the submission on February 23, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K210516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2021 |
| Decision Date | May 16, 2022 |
| Days to Decision | 447 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMG - Stopcock, I.v. Set |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |