Adjustable Multi-Catheter Source Applictor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K062241 ↗

FDA Product Code

JAQ

Device Class

Class II

Regulation

21 CFR Part 892.5700

Advisory Committee

Radiology

FDA Decision

SESU

• Surtrak Implantation Kit

  Class II

  FDA 510(k) K060679 Active Cleared 21 Apr 2006

• Nstrand Implantation Kit

  Class II

  FDA 510(k) K052024 Active Cleared 7 Sep 2005

• North American Scientific (Nasi) 1-125 Radionuclide Brachytherapy Source

  Class II

  FDA 510(k) K964647 Active Cleared 10 Feb 1997

• What is the Adjustable Multi-Cathéter Source Applicator used for?

  This device is designed for precise delivery of radiation in radiology procedures. It allows clinicians to position radioactive sources via multiple adjustable catheters, enabling tailored treatment planning for targeted radiation therapy. The adjustable design ensures flexibility in positioning sources to match specific patient anatomy and treatment requirements.

• Is the Adjustable Multi-Cathéter Source Applicator single-use or reusable?

  The Adjustable Multi-Cathéter Source Applicator is supplied as a reusable system. Proper handling, maintenance, and sterilization protocols must be followed to ensure functionality and safety for repeated use in clinical settings. Reusability helps reduce waste while maintaining performance for multiple procedures.

• How is sterility maintained for this reusable device?

  Since this is a reusable system, sterility is maintained through manufacturer-recommended cleaning, disinfection, and sterilization procedures. Clinicians must adhere to strict protocols to prevent contamination between uses. The device’s design supports these processes, but compliance with validated sterilization methods is critical to ensure patient safety and device integrity.

• What regulatory approval does this device hold?

  The Adjustable Multi-Cathéter Source Applicator holds FDA 510(k) clearance under the product code JAQ, which categorizes it under radiology applications. This clearance confirms that the device meets regulatory standards for safety and effectiveness as a Class II medical device under 21 CFR 892.5700. The clearance number is K062241.

• Are there different models or sizes available for this applicator?

  The provided data does not specify distinct models or sizes beyond the core design of an adjustable multi-cathéter system. However, the device is registered under multiple FEI numbers, which may correspond to variations in components or configurations. For exact specifications, consult the manufacturer’s documentation or technical support, as these details are not explicitly detailed in the regulatory records.