K243045 is an FDA 510(k) clearance for the “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002). This device is classified as a System, Applicator, Radionuclide, Remote-controlled (Class II - Special Controls, product code JAQ).
Submitted by Braxx Biotech Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on November 19, 2024, 53 days after receiving the submission on September 27, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5700.
| 510(k) Number | K243045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2024 |
| Decision Date | November 19, 2024 |
| Days to Decision | 53 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAQ - System, Applicator, Radionuclide, Remote-controlled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5700 |