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FDA 510(k)

“BRAXX” Esophageal Brachytherapy Applicator

K-Number: K183332 · 2019-04-16

ApplicantBraxx Biotech Co., Ltd.
Decision Date2019-04-16
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

“BRAXX” Esophageal Brachytherapy Applicator is a medical device manufactured by Braxx Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-04-16 under approval number K183332. 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?

“BRAXX” Esophageal Brachytherapy Applicator is a medical device that received FDA 510(k) clearance on 2019-04-16. It is manufactured by Braxx Biotech Co., Ltd.. The 510(k) number is K183332.

When was “BRAXX” Esophageal Brachytherapy Applicator approved by the FDA?

“BRAXX” Esophageal Brachytherapy Applicator received FDA 510(k) clearance on 2019-04-16, under approval number K183332.

What company makes “BRAXX” Esophageal Brachytherapy Applicator?

“BRAXX” Esophageal Brachytherapy Applicator is manufactured by Braxx Biotech Co., Ltd..

What is the FDA product code for “BRAXX” Esophageal Brachytherapy Applicator?

The FDA product code for “BRAXX” Esophageal Brachytherapy Applicator 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.

K243045“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)

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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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