SenoRad Multi-Lumen Balloon Source Applicator
FDA 510(k)Class II (US FDA 510(k))
by Senorx, Inc.
Identifiers
- 510(k) Number
- K071229 FDA 510(k)
- FDA Product Code
- JAQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5700 FDA 510(k)
- Regulation Number
- 892.5700 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESU FDA 510(k)
The SenoRad Multi-Lumen Balloon Source Applicator is a remote-controlled radionuclide applicator system designed for brachytherapy. It delivers intracavitary radiation therapy to target tissues, specifically within surgical cavities post-resection, such as those created during lumpectomy procedures.
This device consists of a multi-lumen catheter connected to an inflatable spherical balloon, available in 4 cm or 5 cm diameters with corresponding saline volumes of 32 ml or 55 ml. It is intended for single-use and has received FDA 510(k) clearance under the classification of Class II medical devices (regulation number 892.5700). The applicator is supplied sterile and is regulated under the Radiology specialty category.
Frequently asked questions
What is the primary use of the SenoRad Multi-Lumen Balloon Source Applicator for brachytherapy?
The SenoRad Multi-Lumen Balloon Source Applicator is designed for intracavitary radiation therapy in surgical cavities, such as those created during lumpectomy procedures. It delivers targeted radiation to treat specific tissues within these cavities, helping to control localized disease post-surgery.
Are there different sizes available for the SenoRad Multi-Lumen Balloon Source Applicator, and what are the corresponding saline volumes?
Yes, the device is available in two sizes: a 4 cm diameter balloon with a saline volume of 32 ml, and a 5 cm diameter balloon with a saline volume of 55 ml. These sizes accommodate different cavity dimensions to ensure proper fit and radiation delivery.
How is the SenoRad Multi-Lumen Balloon Source Applicator supplied, and is it intended for single-use?
The device is supplied sterile and is explicitly intended for single-use only. This ensures patient safety and maintains sterility during the procedure, as reusing the applicator is not recommended.
What regulatory pathway was followed for the FDA clearance of this device?
The SenoRad Multi-Lumen Balloon Source Applicator received FDA clearance through a 510(k) submission under the Traditional clearance type. It falls under the Radiology specialty category and is classified as a Class II medical device (regulation number 892.5700). The device was reviewed by the Radiology (RA) Advisory Committee and cleared under the product code JAQ.
How is the balloon inflated during use, and what controls are involved in the procedure?
The device features a multi-lumen catheter connected to an inflatable spherical balloon, which is remotely controlled for precise placement and inflation. The balloon is filled with saline to achieve the desired diameter (4 cm or 5 cm) and maintain proper positioning within the surgical cavity during radiation therapy.
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: Senorad Multi-lumen Balloon Source Applicator for Branchytherapy, Senorad Multi-lumen Balloon Source Applicator for Branchytherapy, PDF SuRXRi - accessdata.fda.gov, Senorad Multi-lumen Balloon Source Applicator for Branchytherapy
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071229 | Class II | Active |
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Manufacturer
- Manufacturer
- Senorx, Inc.
Sources (1)
- FDA 510(k) K071229 24 fields · synced Sep 19, 2026