Surgi-Vision Urethral Coil

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

510(k) Number

K002345 ↗

FDA Product Code

MOS

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Clearpoint System

  Class II

  FDA 510(k) K100836 Active Cleared 16 Jun 2010

• Intercept Esophageal Internal MR Coil, Intercept Urethral Internal MR Coil, and Intercept Vascular Internal MR Coil

  Class II

  FDA 510(k) K020495 Active Cleared 23 Apr 2002

• Endo-Esophageal MR Coil

  Class II

  FDA 510(k) K992193 Active Cleared 3 Sep 1999

• MRI Neuro Drape

  Class II

  FDA 510(k) K091343 Active Cleared 22 Sep 2009

• Surgivision Inc. Clearpoint System

  Class II

  FDA 510(k) K111073 Active Cleared 22 Jun 2011

• Surgi-Vision Prostate Coil

  Class II

  FDA 510(k) K002916 Active Cleared 28 Nov 2000

See all devices from Surgivision, Inc. →

• What is the primary purpose of the Surgi-Vision Urethral Coil in a clinical setting?

  The Surgi-Vision Urethral Coil is specifically designed for use in MRI systems to enhance imaging of anatomical structures in the urethral region. It aids radiologists in achieving high-resolution visualization during MRI scans, ensuring clearer diagnostic images for evaluation.

• Is the Surgi-Vision Urethral Coil intended for single-use or reusable applications?

  The device is explicitly supplied as a reusable medical instrument, meaning it is engineered for repeated use in MRI environments after proper cleaning, sterilization, and maintenance. This aligns with its classification as a Class II reusable device under FDA regulations.

• How do I verify compatibility of the Surgi-Vision Urethral Coil with my MRI system?

  Compatibility is confirmed through the device’s FEI numbers, which are unique identifiers for MRI safety and performance. The coil is listed with multiple FEI numbers (e.g., 3009529630, 3027339477, etc.), ensuring it meets the specific requirements of various MRI systems. Always cross-reference your system’s FEI number with the provided list to ensure proper use.

• What regulatory pathway was followed for FDA clearance of the Surgi-Vision Urethral Coil?

  The device received FDA clearance through a 510(k) premarket notification process under K-number K002345, filed in 2000. The decision was based on a determination of substantial equivalence to a predicate device, with no third-party review required. The clearance was granted under the Radiology advisory committee (RA) and classified under product code MOS (Magnetic Resonance, Specialty).

• Where can I find additional details about the manufacturer or contact information for support?

  For manufacturer details, the Surgi-Vision Urethral Coil is produced by Surgi-Vision, Inc., headquartered at 9250 Rumsey Rd., Suite 100, Columbia, MD 21045. For inquiries or support, you may contact Nancy E. Taylor, though direct contact methods (e.g., phone/email) are not provided in the regulatory data. Always verify current contact information through official channels.