Cleared Traditional

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

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911349 · E-Z-Em, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
600d
Days
Class 2
Risk

K911349 is an FDA 510(k) clearance for the E-Z-EM ENTEROCLYSIS CATHETER SET. Classified as Catheter, Retention Type (product code EZK), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on November 16, 1992 after a review of 600 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all E-Z-Em, Inc. devices

Submission Details

510(k) Number K911349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
470d slower than avg
Panel avg: 130d · This submission: 600d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZK Catheter, Retention Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.