Clearance Summary
MIDWIFERY/OBSTETRICAL FORCEPS received FDA 510(k) clearance under submission number K890385, sponsored by Kinetic Medical Products. 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 1989-03-01.
- Submission: K890385
- Applicant / Sponsor: Kinetic Medical Products
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4400
- Decision date: 1989-03-01
Classification & Regulation
This clearance is catalogued under FDA product code HDA and 21 CFR 884.4400, within the Obstetrics/Gynecology review panel as a Class II device.