K161547 is an FDA 510(k) clearance for the Transem and EchoGen Embryo Transfer Catheters. This device is classified as a Catheter, Assisted Reproduction (Class II - Special Controls, product code MQF).
Submitted by Origio A/S (Måløv, DK). The FDA issued a Cleared decision on March 9, 2017, 279 days after receiving the submission on June 3, 2016.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6110.
| 510(k) Number | K161547 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2016 |
| Decision Date | March 09, 2017 |
| Days to Decision | 279 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQF - Catheter, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6110 |