Isoaid Iodine Brachtherapy Seeds, Model Advantage I-125
FDA 510(k) K011205 · Isoaid
510(k) numberK011205
Submission
- Device name
- Isoaid Iodine Brachtherapy Seeds, Model Advantage I-125
- Applicant
- Isoaid
Appollo Beach, FL, US - Received
- April 19, 2001
- Decision date
- July 10, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KXK
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| K252296 | OncoPatchKXK · Traditional | Oncopatch, Inc. | 12/05/2025SE |
| K242818 | IsoSphereKXK · Traditional | Isoaid, LLC | 07/15/2025SE |
| K223465 | RadianceTx Radionuclide Brachytherapy SourceKXK · Traditional | Radiance Therapeutics, Inc. | 01/11/2023SE |
| K221539 | GammaTileKXK · Traditional | Gt Medical Technologies | 11/09/2022SE |
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| K190839 | GammaTileKXK · Traditional | Gt Medical Technologies | 01/23/2020SE |
| K191324 | CivaDermKXK · Traditional | Civatech Oncology, Inc. | 09/20/2019SE |
| K190296 | GammaTileKXK · Special | Gt Medical Technologies | 03/13/2019SE |
| K180515 | GammaTileKXK · Traditional | Isoray Medical, Inc. | 07/06/2018SE |
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 |
| K091117 | Advantage-Strand/ Advantage-Load Brachytherapy Kit, Model IaslbkaKXK · Traditional | 09/15/2009SE |
| K033770 | Isoaid Advantage PD-103, Model IAPD-103AKXK · Traditional | 04/08/2004SE |
Questions and answers
When was Isoaid Iodine Brachtherapy Seeds, Model Advantage I-125 cleared by the FDA?
Isoaid Iodine Brachtherapy Seeds, Model Advantage I-125 (K011205) received a 510(k) decision of Substantially Equivalent on July 10, 2001, 82 days after the submission was received.
What is the product code of K011205?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.