# K994436: Surgi-Vision Esophageal Stylet Coil

- Pathway: 510(k) (Traditional)
- Applicant: Surgi-Vision, Inc.
- Decided: Mar 14, 2000 after 75 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: 2 generations back to K952232 (1995). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992193: Endo-Esophageal MR Coil, Surgi-Vision, Inc. (1999) Summary page 1.

## 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 Surgi-Vision Esophageal Stylet Coil is recommended for high-resolution Magnetic Resonance Imaging of the human esophagus. The single use, disposable coil has been designed to be inserted in 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 a 1.5T MRI machine.

Source page: https://510kreport.com/device/K994436
Methodology: https://510kreport.com/methodology