K231554 is an FDA 510(k) clearance for the UniPearls® Embolic Microspheres. This device is classified as a Device, Vascular, For Promoting Embolization (Class II - Special Controls, product code KRD).
Submitted by Suzhou Haowei Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on November 14, 2023, 168 days after receiving the submission on May 30, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K231554 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2023 |
| Decision Date | November 14, 2023 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KRD - Device, Vascular, For Promoting Embolization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3300 |