# K011781: Intercept-Urethral Microcoil

- Pathway: 510(k) (Traditional)
- Applicant: Surgi-Vision, Inc.
- Decided: Aug 31, 2001 after 85 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: 1 generation back to K002916 (2000). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002916: Surgi-Vision Prostate Coil, Surgi-Vision, Inc. (2000) Summary page 2.

## Most influential descendants
- K020790: Intercept Esophageal Internal MR Coil, Intercept Urethral Microcoil, and Intercept Vascular Internal MR Coil (2002), 0 descendants of its own
- K020495: Intercept Esophageal Internal MR Coil, Intercept Urethral Internal MR Coil, and Intercept Vascular Internal MR Coil (2002), 0 descendants of its own

## Indications for use
The Intercept-Urethral Microcoil 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 the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the urethra including the prostate in males. The flexible coil facilitates placement of the coil in the anatomy. This product is to be used with a 1.5T GE Signa MRI machine. 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.

Source page: https://510kreport.com/device/K011781
Methodology: https://510kreport.com/methodology