K170498 is an FDA 510(k) clearance for the Gems Oocyte Retrieval Buffer ORB-20, ORB-50, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Genea Biomedx Pty, Ltd. (Sydney, AU). The FDA issued a Cleared decision on September 28, 2017, 223 days after receiving the submission on February 17, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K170498 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 17, 2017 |
| Decision Date | September 28, 2017 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQL — Media, Reproductive |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6180 |