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FDA 510(k)

“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)

K-Number: K243045 · 2024-11-19

ApplicantBraxx Biotech Co., Ltd.
Decision Date2024-11-19
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) is a medical device manufactured by Braxx Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-11-19 under approval number K243045. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)?

“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) is a medical device that received FDA 510(k) clearance on 2024-11-19. It is manufactured by Braxx Biotech Co., Ltd.. The 510(k) number is K243045.

When was “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) approved by the FDA?

“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) received FDA 510(k) clearance on 2024-11-19, under approval number K243045.

What company makes “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)?

“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) is manufactured by Braxx Biotech Co., Ltd..

What is the FDA product code for “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)?

The FDA product code for “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) is JAQ.

Related Clinical Trials

NCT05145647 To Observe the Benefit of Adding Brachytherapy After CCRT on Resectable Esophageal Cancer Patients Without Surgery ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41967338 Patient-tailored brachytherapy applicator development in compliance with the EU medical device regulation. Physica medica : PM : an international journal devoted to the applications of physics to medicine and biology : official journal of the Italian Association of Biomedical Physics (AIFB) (2026)

Other Devices by Braxx Biotech Co., Ltd.

K183332“BRAXX” Esophageal Brachytherapy Applicator

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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