K193522 is an FDA 510(k) clearance for the iMedium Single Step. This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).
Submitted by Kitazato Corporation (Fuji-Shi, JP). The FDA issued a Cleared decision on August 25, 2020, 250 days after receiving the submission on December 19, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K193522 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2019 |
| Decision Date | August 25, 2020 |
| Days to Decision | 250 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 |