510(k) K172151
K172151 is an FDA 510(k) premarket notification submitted by Chongquin Jinshan Science & Technology (Group) Co., Ltd. for the device "Hysteroscopy System". The FDA issued a decision of Substantially Equivalent on April 9, 2018. The device falls under product code HGH (Cannula, Suction, Uterine), a Class II device regulated under 21 CFR 884.5070.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 2018
- Date Received
- July 17, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Suction, Uterine
- Device Class
- Class II
- Regulation Number
- 884.5070
- Review Panel
- OB
- Submission Type