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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 the device name listed in this FDA 510(k) record. The listed applicant is Braxx Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-11-19 under 510(k) 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. The listed applicant is Braxx Biotech Co., Ltd.. The 510(k) number is K243045.

When did “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) receive FDA 510(k) clearance?

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

Who is the listed applicant for “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)?

The FDA 510(k) record lists Braxx Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05145647To Observe the Benefit of Adding Brachytherapy After CCRT on Resectable Esophageal Cancer Patients Without SurgeryACTIVE_NOT_RECRUITING

Other records listing Braxx Biotech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183332“BRAXX” Esophageal Brachytherapy Applicator

Related Devices (Code: JAQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262383LumenCare AzureNucletron B.V.K252717MAASTRO Rectal Applicator SetVarian Medical SystemsK251037Rectal ApplicatorNucletron B.V.K252884Guided Aarhus Applicator SetVarian Medical SystemsK250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.K250289Intracavitary/Interstitial SystemVarian Medical Systems

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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