K171736 is an FDA 510(k) clearance for the Geri Embryo Incubator and Geri Dish, a Accessory, Assisted Reproduction (Class II — Special Controls, product code MQG), submitted by Genea Biomedx Pty, Ltd. (Sydney, AU). The FDA issued a Cleared decision on November 15, 2017, 156 days after receiving the submission on June 12, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6120.
| 510(k) Number | K171736 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 12, 2017 |
| Decision Date | November 15, 2017 |
| Days to Decision | 156 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQG — Accessory, Assisted Reproduction |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6120 |