Clearance Summary
YUSHENG DISPOSABLE VAGINAL SPECULUM received FDA 510(k) clearance under submission number K052912, sponsored by Zhejiang Yusheng Medical Instrument 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 2005-12-15.
- Submission: K052912
- Applicant / Sponsor: Zhejiang Yusheng Medical Instrument Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2005-12-15
Classification & Regulation
This clearance is catalogued under FDA product code HIB and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.