510(k) K183332
K183332 is an FDA 510(k) premarket notification submitted by Braxx Biotech Co., Ltd. for the device "BRAXX Esophageal Brachytherapy Applicator". The FDA issued a decision of Substantially Equivalent on April 16, 2019. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Braxx Biotech Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 2019
- Date Received
- December 3, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Applicator, Radionuclide, Remote-Controlled
- Device Class
- Class II
- Regulation Number
- 892.5700
- Review Panel
- RA
- Submission Type