K220926 is an FDA 510(k) clearance for the Spectra Wearable, a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Uzinmedicare Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on December 12, 2022, 256 days after receiving the submission on March 31, 2022. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K220926 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 31, 2022 |
| Decision Date | December 12, 2022 |
| Days to Decision | 256 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 |