FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
K Number: K243045
·
Decision Nov 19, 2024
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
206
Applicant Total
2
Review Days
53
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Basic Information
- Device Name
- BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
- K Number
- K243045
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Braxx Biotech Co., Ltd.
- Date Received
- September 27, 2024
- Decision Date
- November 19, 2024
- Product Code
- JAQ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | FDA class 2 | Radiology |
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Other Clearances by Braxx Biotech Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K183332 | BRAXX Esophageal Brachytherapy Applicator | Apr 16, 2019 | Substantially Equivalent |