K153267 is an FDA 510(k) clearance for the ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash. This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).
Submitted by Origio A/S (Måløv, DK). The FDA issued a Cleared decision on July 22, 2016, 253 days after receiving the submission on November 12, 2015.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K153267 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2015 |
| Decision Date | July 22, 2016 |
| Days to Decision | 253 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 |