K210562 is an FDA 510(k) clearance for the HRSpheres Narrow-Size Embolic Microspheres. This device is classified as a Device, Vascular, For Promoting Embolization (Class II - Special Controls, product code KRD).
Submitted by Suzhou Hengrui Hongyuan Medical Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on October 1, 2021, 218 days after receiving the submission on February 25, 2021.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K210562 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2021 |
| Decision Date | October 01, 2021 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | KRD - Device, Vascular, For Promoting Embolization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3300 |