K140213 is an FDA 510(k) clearance for the DISPOSABLE ENDOSCOPIC CANNULA, a Cannula, Suction, Uterine (Class II — Special Controls, product code HGH), submitted by Dongguan Microview Medical Technology Co., Ltd. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on March 25, 2015, 421 days after receiving the submission on January 28, 2014. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5070.
| 510(k) Number | K140213 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 28, 2014 |
| Decision Date | March 25, 2015 |
| Days to Decision | 421 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGH — Cannula, Suction, Uterine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5070 |