Clearance Summary
FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 received FDA 510(k) clearance under submission number K061651, sponsored by Apple Medical Corp.. 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 2006-10-20.
- Submission: K061651
- Applicant / Sponsor: Apple Medical Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4120
- Decision date: 2006-10-20
Classification & Regulation
This clearance is catalogued under FDA product code HGI and 21 CFR 884.4120, within the Obstetrics/Gynecology review panel as a Class II device.