K173624 is an FDA 510(k) clearance for the ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311). 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 March 2, 2018, 98 days after receiving the submission on November 24, 2017.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K173624 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2017 |
| Decision Date | March 02, 2018 |
| Days to Decision | 98 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 |