Cleared Traditional

K020790 - INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COIL
(FDA 510(k) Clearance)

K020790 · Surgi-Vision, Inc. · Radiology

May 2002

Decision

71d

Days

Class 2

Risk

K020790 is an FDA 510(k) clearance for the INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COIL. This device is classified as a Coil, Magnetic Resonance, Specialty (Class II — Special Controls, product code MOS).

Submitted by Surgi-Vision, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on May 21, 2002, 71 days after receiving the submission on March 11, 2002.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number	K020790 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 2002
Decision Date	May 21, 2002
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF