# K020495: Intercept Esophageal Internal MR Coil, Intercept Urethral Internal MR Coil, and Intercept Vascular Internal MR Coil

- Pathway: 510(k) (Traditional)
- Applicant: Surgi-Vision, Inc.
- Decided: Apr 23, 2002 after 68 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K952232 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994436: Surgi-Vision Esophageal Stylet Coil, Surgi-Vision, Inc. (2000) Summary page 1.
- K011781: Intercept-Urethral Microcoil, Surgi-Vision, Inc. (2001) Summary page 1.
- K003436: Surgi-Vision Guidewire Coil, Surgi-Vision, Inc. (2001) Summary page 1.

## Indications for use
The Intercept™ Esophageal Internal MR Coil is recommended for high-resolution Magnetic Resonance Imaging of the human esophagus. The single use, disposable coil is designed for insertion into the esophagus of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the esophagus. The unique coil shape facilitates orientation of the coil to the anatomy. This product is to be used with Siemens 1.5T MRI systems. The Intercept™ Urethral Internal MR Coil is recommended for high-resolution Magnetic Resonance Imaging of the male and female urethra and surrounding tissue. The single use, disposable coil was designed to be inserted in the urethra of a patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the urethra and including the prostate in males. The flexible coil facilitates placement of the coil in the anatomy. This product is to be used with Siemens 1.5T MRI systems. The signals picked up by the coil are conducted through a small coaxial cable to a connection with the standard surface coil connector for MRI systems. The coil and cable are completely sealed inside the insulating layer. The Intercept™ Vascular Internal MR Coil is recommended for high-resolution Magnetic Resonance Imaging of the peripheral vasculature. The single use, disposable coil is designed for insertion into an artery or vein of a patient during MRI scans in order to obtain improved image quality in the peripheral vasculature. The flexible coil facilitates placement of the coil in the peripheral vascular anatomy. The coil would most commonly be used through femoral artery access similar to .035” guidewires currently in use. The handling characteristics of this device are familiar to vascular interventionalists thereby facilitating integration into their practices. This product is to be used with Siemens 1.5T MRI systems.

Source page: https://510kreport.com/device/K020495
Methodology: https://510kreport.com/methodology