Best Multi-Lumen Balloon Applicator for Brachytherapy
FDA 510(k) K132097 · Best Medical International, Inc.
510(k) numberK132097
Submission
- Device name
- Best Multi-Lumen Balloon Applicator for Brachytherapy
- Applicant
- Best Medical International, Inc.
Springfield, VA, US - Received
- July 8, 2013
- Decision date
- September 30, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K241764 | Mould Probe MR SafeJAQ · Traditional | Varian Medical Systems, Inc. | 01/10/2025SE |
| K242961 | Intraluminal Applicator SetJAQ · Traditional | Varian Medical Systems | 11/26/2024SE |
| K243045 | BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)JAQ · Special | Braxx Biotech Co., Ltd. | 11/19/2024SE |
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| K162499 | Best Instruminal ApplicatorJAQ · Traditional | 04/13/2018SE |
| K061638 | Best Strand and Best SpacerKXK · Traditional | 08/04/2006SE |
| K043117 | Best Radiopaque Strand; Best Radiopaque MarkerKXK · Traditional | 12/09/2004SE |
| K042786 | Best Model # 81-01 Series IR-192 SourcesKXK · Abbreviated | 11/18/2004SE |
| K042586 | Best Breast Brachytherapy ApplicatorJAQ · Traditional | 11/03/2004SE |
Questions and answers
When was Best Multi-Lumen Balloon Applicator for Brachytherapy cleared by the FDA?
Best Multi-Lumen Balloon Applicator for Brachytherapy (K132097) received a 510(k) decision of Substantially Equivalent on September 30, 2013, 84 days after the submission was received.
What is the product code of K132097?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.