Clearance Summary
BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) received FDA 510(k) clearance under submission number K243045, sponsored by Braxx Biotech Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2024-11-19.
- Submission: K243045
- Applicant / Sponsor: Braxx Biotech Co., Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 2024-11-19
Classification & Regulation
This clearance is catalogued under FDA product code JAQ and 21 CFR 892.5700, within the Radiology review panel as a Class II device.