K120877 is an FDA 510(k) clearance for the MICROMANIPULATOR SET. This device is classified as a Micromanipulators And Microinjectors, Assisted Reproduction (Class II - Special Controls, product code MQJ).
Submitted by Narishige Co., Ltd. (Setagaya-Ku, Tokyo, JP). The FDA issued a Cleared decision on June 20, 2012, 89 days after receiving the submission on March 23, 2012.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6150.
| 510(k) Number | K120877 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2012 |
| Decision Date | June 20, 2012 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQJ — Micromanipulators And Microinjectors, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6150 |