Clearance Summary
CERVICAL-VAGINAL SPATULA received FDA 510(k) clearance under submission number K761348, sponsored by Law Offices of Natter & Natter. 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 1977-01-18.
- Submission: K761348
- Applicant / Sponsor: Law Offices of Natter & Natter
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1977-01-18
Classification & Regulation
This clearance is catalogued under FDA product code HHT and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.