Clearance Summary
OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM received FDA 510(k) clearance under submission number K091937, sponsored by Obp Corporation. 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 2009-09-09.
- Submission: K091937
- Applicant / Sponsor: Obp Corporation
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2009-09-09
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.