Clearance Summary
SEDLACEK HANDLE received FDA 510(k) clearance under submission number K926179, sponsored by Simpson/Basye, 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 1994-03-25.
- Submission: K926179
- Applicant / Sponsor: Simpson/Basye, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4120
- Decision date: 1994-03-25
Classification & Regulation
This clearance is catalogued under FDA product code HGI and 21 CFR 884.4120, within the Obstetrics/Gynecology review panel as a Class II device.