Advantage-Strand/ Advantage-Load Brachytherapy Kit, Model Iaslbka
FDA 510(k) K091117 · Isoaid, LLC
510(k) numberK091117
Submission
- Device name
- Advantage-Strand/ Advantage-Load Brachytherapy Kit, Model Iaslbka
- Applicant
- Isoaid, LLC
Port Richey, FL, US - Received
- April 17, 2009
- Decision date
- September 15, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Isoray Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242818 | IsoSphereKXK · Traditional | 07/15/2025SE |
| K141701 | I-125 RSLN [Radioactive Seed and Localization Needle]KXK · Traditional | 12/05/2014SE |
| K113210 | Advantage-Strand/Advantage-Load Brachytherapy KitKXK · Traditional | 08/10/2012SE |
| K033770 | Isoaid Advantage PD-103, Model IAPD-103AKXK · Traditional | 04/08/2004SE |
| K011205 | Isoaid Iodine Brachtherapy Seeds, Model Advantage I-125KXK · Traditional | 07/10/2001SE |
Questions and answers
When was Advantage-Strand/ Advantage-Load Brachytherapy Kit, Model Iaslbka cleared by the FDA?
Advantage-Strand/ Advantage-Load Brachytherapy Kit, Model Iaslbka (K091117) received a 510(k) decision of Substantially Equivalent on September 15, 2009, 151 days after the submission was received.
What is the product code of K091117?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.