Clearance Summary
KOLPLAST VAGINAL SPECULUM received FDA 510(k) clearance under submission number K973853, sponsored by Kolplast Comercial E Industrial Ltda. 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 1997-12-19.
- Submission: K973853
- Applicant / Sponsor: Kolplast Comercial E Industrial Ltda
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1997-12-19
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.