Clearance Summary
BIOPSY HANDY, MRI BIOPSY HANDY received FDA 510(k) clearance under submission number K102771, sponsored by Somatex Medical Technologies GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2011-06-24.
- Submission: K102771
- Applicant / Sponsor: Somatex Medical Technologies GmbH
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2011-06-24
Classification & Regulation
This clearance is catalogued under FDA product code KNW and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.