Best Instruminal Applicator
FDA 510(k) K162499 · Best Medical International, Inc.
510(k) numberK162499
Submission
- Device name
- Best Instruminal Applicator
- Applicant
- Best Medical International, Inc.
Springfield, VA, US - Received
- September 7, 2016
- Decision date
- April 13, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K132097 | Best Multi-Lumen Balloon Applicator for BrachytherapyJAQ · Traditional | 09/30/2013SE |
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| 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 Instruminal Applicator cleared by the FDA?
Best Instruminal Applicator (K162499) received a 510(k) decision of Substantially Equivalent on April 13, 2018, 583 days after the submission was received.
What is the product code of K162499?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.