Clearance Summary
VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L received FDA 510(k) clearance under submission number K022948, sponsored by Medical Action Industries, 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 2002-11-04.
- Submission: K022948
- Applicant / Sponsor: Medical Action Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2002-11-04
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.