K200248 is an FDA 510(k) clearance for the Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators. This device is classified as a Catheter, Assisted Reproduction (Class II - Special Controls, product code MQF).
Submitted by Allwin Medical Devices, Inc. (Anaheim, US). The FDA issued a Cleared decision on July 1, 2020, 152 days after receiving the submission on January 31, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6110.
| 510(k) Number | K200248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2020 |
| Decision Date | July 01, 2020 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | MQF - Catheter, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6110 |