Esophageal Stylet Coil

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

Full name

Surgi-Vision Esophageal Stylet Coil

510(k) Number

K994436 ↗

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 Surgi-Vision Esophageal Stylet Coil used for?

  The Surgi-Vision Esophageal Stylet Coil is a specialty magnetic resonance coil intended to improve image resolution of the esophagus and adjacent anatomical regions during high-resolution MRI scans. By positioning the coil directly within the esophagus, it enhances signal clarity, aiding radiologists in obtaining detailed diagnostic images.

• How is the Esophageal Stylet Coil supplied and prepared for use?

  The coil is supplied sterile and as a single-use, disposable device. This ensures patient safety and reduces the risk of cross-contamination between procedures. Clinicians should follow manufacturer guidelines for proper handling, insertion, and disposal to maintain sterility and functionality.

• Is the coil reusable or intended for multi-patient use?

  No, the Esophageal Stylet Coil is explicitly designed for single-use only. The manufacturer does not provide specifications or recommendations for reuse or multi-patient applications, emphasizing its disposable nature for clinical safety and compliance.

• What regulatory pathway does this device follow?

  The Surgi-Vision Esophageal Stylet Coil has undergone FDA review through the 510(k) clearance process, specifically classified under the Radiology advisory committee. It was determined to be substantially equivalent to a predicate device, receiving clearance on March 14, 2000, under the traditional review pathway.

• Are there any specific storage requirements for the coil?

  While the provided data does not explicitly detail storage conditions, as a sterile, single-use device, it should be stored in a clean, dry environment protected from physical damage or contamination. Follow the manufacturer’s instructions for packaging and storage to preserve sterility and functionality until use.