Surgi-Vision Guidewire Coil

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

510(k) Number

K003436 ↗

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

• Surgi-Vision Urethral Coil

  Class II

  FDA 510(k) K002345 Active Cleared 11 Oct 2000

• Surgivision Inc. Clearpoint System

  Class II

  FDA 510(k) K111073 Active Cleared 22 Jun 2011

See all devices from Surgivision, Inc. →

• What is the primary purpose of the Surgi-Vision Guidewire Coil in MRI systems?

  The Surgi-Vision Guidewire Coil is designed to enhance imaging quality in MRI systems by improving signal reception and spatial resolution. This makes it particularly useful for detailed visualization of soft tissues, which is critical in radiology applications where fine anatomical details are essential for accurate diagnosis.

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

  The Surgi-Vision Guidewire Coil is explicitly supplied as a reusable component for MRI scanners. There is no indication in the data that it requires disposal after use, so it is meant to be integrated into MRI systems for repeated imaging sessions.

• What regulatory pathway was followed for FDA clearance of this device?

  The Surgi-Vision Guidewire Coil received FDA clearance through a 510(k) premarket notification process, specifically under the Traditional Review pathway. It was determined to be substantially equivalent to a predicate device and falls under the Magnetic Resonance Diagnostic Device category (regulation number 892.1000). The advisory committee involved was the Radiology (RA) Committee.

• Are there multiple models or sizes available for the Surgi-Vision Guidewire Coil?

  Yes, the data lists multiple FEI (Final Establishment Identification) numbers, indicating that the Surgi-Vision Guidewire Coil is available in various models or configurations. These variations may correspond to different MRI system compatibilities or coil specifications, though exact sizes or technical differences are not detailed in the provided data.

• How should the Surgi-Vision Guidewire Coil be stored, and are there any special handling requirements?

  While the data does not specify storage conditions explicitly, as a reusable MRI component, it should be stored in a clean, dry environment to prevent contamination or damage. Since it is designed for integration into MRI systems, proper handling—such as avoiding exposure to magnetic fields or physical stress—is likely recommended to maintain functionality. Always refer to the manufacturer’s instructions for precise storage guidelines.