K190590 is an FDA 510(k) clearance for the Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle). This device is classified as a Needle, Assisted Reproduction (Class II - Special Controls, product code MQE).
Submitted by Allwin Medical Devices, Inc. (Anaheim, US). The FDA issued a Cleared decision on November 25, 2019, 263 days after receiving the submission on March 7, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6100.
| 510(k) Number | K190590 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2019 |
| Decision Date | November 25, 2019 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | MQE - Needle, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6100 |