K162881 is an FDA 510(k) clearance for the Kitazato OPU Needles. This device is classified as a Needle, Assisted Reproduction (Class II - Special Controls, product code MQE).
Submitted by Kitazato Corporation (Tokyo, JP). The FDA issued a Cleared decision on July 11, 2017, 270 days after receiving the submission on October 14, 2016.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6100.
| 510(k) Number | K162881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 2016 |
| Decision Date | July 11, 2017 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQE - Needle, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6100 |