K223329 is an FDA 510(k) clearance for the Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201). This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Guangzhou Yongyi Industrial Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on May 26, 2023, 207 days after receiving the submission on October 31, 2022.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K223329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2022 |
| Decision Date | May 26, 2023 |
| Days to Decision | 207 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGX - Pump, Breast, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5160 |