Submission Details
| 510(k) Number | K172151 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 17, 2017 |
| Decision Date | April 09, 2018 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
Hysteroscopy System
Apr 2018
Decision
266d
Days
Class 2
Risk
About This 510(k) Submission
K172151 is an FDA 510(k) clearance for the Hysteroscopy System, a Cannula, Suction, Uterine (Class II — Special Controls, product code HGH), submitted by Chongquin Jinshan Science & Technology (Group) Co., Ltd. (Chongqing, CN). The FDA issued a Cleared decision on April 9, 2018, 266 days after receiving the submission on July 17, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5070.
Device Classification
| Product Code | HGH — Cannula, Suction, Uterine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5070 |
Manufacturer
Chongquin Jinshan Science & Technology (Group) Co., Ltd.
Chongqing · CN
Qing Xu
1 submissions
1 cleared
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