Clearance Summary
BRELLA-SPEC(TM) VAGINAL SPECULUM received FDA 510(k) clearance under submission number K133857, sponsored by Proa Medical, Inc.. 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 2014-04-28.
- Submission: K133857
- Applicant / Sponsor: Proa Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2014-04-28
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.