K232934 is an FDA 510(k) clearance for the Sunsphere. This device is classified as a Device, Vascular, For Promoting Embolization (Class II - Special Controls, product code KRD).
Submitted by Hangzhou Yangshun Medical Technology Co.,Ltd (Hangzhou, CN). The FDA issued a Cleared decision on May 30, 2024, 253 days after receiving the submission on September 20, 2023.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K232934 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2023 |
| Decision Date | May 30, 2024 |
| Days to Decision | 253 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 |