Clearance Summary
MADDEN SURGICAL THIMBLE received FDA 510(k) clearance under submission number K940907, sponsored by Kelley-Gilmer Medical Corp.. 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 1994-12-29.
- Submission: K940907
- Applicant / Sponsor: Kelley-Gilmer Medical Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1994-12-29
Classification & Regulation
This clearance is catalogued under FDA product code KNA and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.