Cleared Traditional

K911349 - E-Z-EM ENTEROCLYSIS CATHETER SET
(FDA 510(k) Clearance)

K911349 · E-Z-Em, Inc. · Gastroenterology & Urology
Nov 1992
Decision
600d
Days
Class 2
Risk

K911349 is an FDA 510(k) clearance for the E-Z-EM ENTEROCLYSIS CATHETER SET, a Catheter, Retention Type (Class II — Special Controls, product code EZK), submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on November 16, 1992, 600 days after receiving the submission on March 27, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K911349 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 1991
Decision Date November 16, 1992
Days to Decision 600 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code EZK — Catheter, Retention Type
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5980