Clearance Summary
FAS SET #4551 received FDA 510(k) clearance under submission number K013497, sponsored by Gynetics Medical Products NV. 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 2001-11-09.
- Submission: K013497
- Applicant / Sponsor: Gynetics Medical Products NV
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6100
- Decision date: 2001-11-09
Classification & Regulation
This clearance is catalogued under FDA product code MQE and 21 CFR 884.6100, within the Obstetrics/Gynecology review panel as a Class II device.