Clearance Summary
ORIBRUSH - STANDARD - B002 received FDA 510(k) clearance under submission number K991593, sponsored by Orifice Medical AB. 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 1999-06-29.
- Submission: K991593
- Applicant / Sponsor: Orifice Medical AB
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1999-06-29
Classification & Regulation
This clearance is catalogued under FDA product code HHT and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.