Clearance Summary
BRACHYTHERAPY STRAND DEVICE received FDA 510(k) clearance under submission number K040339, sponsored by Bebig Isotopen-Und Medizintechnik GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2004-04-08.
- Submission: K040339
- Applicant / Sponsor: Bebig Isotopen-Und Medizintechnik GmbH
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5730
- Decision date: 2004-04-08
Classification & Regulation
This clearance is catalogued under FDA product code KXK and 21 CFR 892.5730, within the Radiology review panel as a Class II device.