Clearance Summary
Hysteroscopy System received FDA 510(k) clearance under submission number K172151, sponsored by Chongquin Jinshan Science & Technology (Group) Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2018-04-09.
- Submission: K172151
- Applicant / Sponsor: Chongquin Jinshan Science & Technology (Group) Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5070
- Decision date: 2018-04-09
Classification & Regulation
This clearance is catalogued under FDA product code HGH and 21 CFR 884.5070, within the Obstetrics/Gynecology review panel as a Class II device.