Brachysource Brachytherapy Seed Implants
FDA 510(k) K043246 · C.R. Bard, Inc.
510(k) numberK043246
Submission
- Device name
- Brachysource Brachytherapy Seed Implants
- Applicant
- C.R. Bard, Inc.
Covington, GA, US - Received
- November 23, 2004
- Decision date
- February 2, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KXK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K202267 | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesKXK · Traditional | Isoray Medical, Inc. | 12/31/2020SE |
| K193602 | LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceKXK · Special | Lv Liberty Vision Corporation | 05/29/2020SE |
| 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 |
|---|---|---|
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | 07/10/2026SE |
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter KitFCM · Traditional | 05/29/2026SESK |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser…GEX · Traditional | 03/17/2026SE |
| K251864 | Rubber Utility CatheterKOD · Traditional | 02/23/2026SE |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…LDF · Traditional | 01/31/2025SE |
| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | 03/31/2023SE |
| K223177 | Highlander 014 PTA Balloon Dilatation CatheterLIT · Traditional | 01/20/2023SE |
| K222793 | WavelinQ GeneratorGEI · Special | 10/17/2022SE |
| K220270 | Aspirex Thrombectomy SystemQEW · Traditional | 06/21/2022SE |
Questions and answers
When was Brachysource Brachytherapy Seed Implants cleared by the FDA?
Brachysource Brachytherapy Seed Implants (K043246) received a 510(k) decision of Substantially Equivalent on February 2, 2005, 71 days after the submission was received.
What is the product code of K043246?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.