Clearance Summary
MODIFIED DISPOSABLE FETAL VACUUM received FDA 510(k) clearance under submission number K915763, sponsored by Columbia Medical & Surgical, 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 1992-03-18.
- Submission: K915763
- Applicant / Sponsor: Columbia Medical & Surgical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4340
- Decision date: 1992-03-18
Classification & Regulation
This clearance is catalogued under FDA product code HDB and 21 CFR 884.4340, within the Obstetrics/Gynecology review panel as a Class II device.