Clearance Summary
FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I received FDA 510(k) clearance under submission number K052192, sponsored by Femspec LLC. 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 2006-02-02.
- Submission: K052192
- Applicant / Sponsor: Femspec LLC
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2006-02-02
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.