Spectrum Silicone Foley Catheter

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K000251 ↗

FDA Product Code

MJC

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Cook Urological, Inc. →

• What clinical settings is the Spectrum Silicone Foley Catheter intended for use in?

  The Spectrum Silicone Foley Catheter is designed for single-use in both hospital and outpatient care settings, where urinary drainage is required. Its silicone construction and sterile packaging make it suitable for a variety of clinical environments where biocompatibility and ease of insertion are priorities.

• Is the Spectrum Silicone Foley Catheter reusable, or is it meant for one-time use?

  The device is explicitly labeled for single-use only, meaning it should not be reused after a single patient application. This aligns with standard urological catheter practices to minimize infection risks and ensure patient safety.

• How is the Spectrum Silicone Foley Catheter supplied, and what does that mean for handling?

  The catheter is supplied sterile, which means it is pre-packaged and ready for immediate clinical use without additional sterilization. This ensures sterility is maintained until first use, reducing contamination risks during handling and insertion.

• What materials is the Spectrum Silicone Foley Catheter made from, and why does that matter?

  The catheter is constructed from silicone, a material chosen for its biocompatibility and smooth texture, which facilitates easier insertion compared to other materials. This reduces patient discomfort and trauma during use.

• How do I identify the correct size or model for my patient’s needs?

  The Spectrum Silicone Foley Catheter comes in multiple sizes and models, as indicated by the listed FEI numbers (e.g., 1000237915, 3003058448). While the exact sizing isn’t detailed here, the product code MJC and regulatory classification under 876.5130 suggest compliance with standard urological drainage guidelines. Always refer to the packaging or manufacturer’s sizing charts to match the catheter to your patient’s anatomical requirements.