Brachysource Seed Implants With Sourcecap Bioabsorbable Caps
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140856 FDA 510(k)
- FDA Product Code
- KXK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5730 FDA 510(k)
- Regulation Number
- 892.5730 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Brachysource Seed Implants With Sourcecap Bioabsorbable Caps are permanent interstitial brachytherapy sources. The device consists of a welded titanium capsule containing Iodine-125 adsorbed onto gold-cored aluminum wire, fitted with bioabsorbable copolymer caps at each end. These caps increase surface area to resist seed migration within tissue.
The device is supplied as a permanent implant and is used to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors. The bioabsorbable caps degrade over time and are made of 70% L-lactide/30% DL-lactide copolymer. The device has FDA 510(k) clearance with product code KXK.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Brachysource Seed Implants With Sourcecap Bioabsorbable Caps (K140856 ..., Brachysource Seed Implants With Sourcecap Bioabsorbable Caps, SourceCap™ Bioabsorbable Endcaps | BD
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140856 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K140856 24 fields · synced Sep 23, 2026