K191291 is an FDA 510(k) clearance for the Wallace Dual Lumen Oocyte Recovery System. This device is classified as a Needle, Assisted Reproduction (Class II - Special Controls, product code MQE).
Submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on June 12, 2019, 29 days after receiving the submission on May 14, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6100.
| 510(k) Number | K191291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2019 |
| Decision Date | June 12, 2019 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQE — Needle, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6100 |