Clearance Summary
TEKNO-MEDICAL OBSTETRICAL FORCEPS received FDA 510(k) clearance under submission number K013747, sponsored by Tekno Medical Optik-Chirurgie GmbH & Co.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2002-02-11.
- Submission: K013747
- Applicant / Sponsor: Tekno Medical Optik-Chirurgie GmbH & Co.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4400
- Decision date: 2002-02-11
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.