Clearance Summary
Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) received FDA 510(k) clearance under submission number K190797, sponsored by Reed Medical (Zhejiang) 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 2019-11-18.
- Submission: K190797
- Applicant / Sponsor: Reed Medical (Zhejiang) Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1690
- Decision date: 2019-11-18
Classification & Regulation
This clearance is catalogued under FDA product code HIH and 21 CFR 884.1690, within the Obstetrics/Gynecology review panel as a Class II device.