Cleared Traditional

K841720 - E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS (FDA 510(k) Clearance)

K841720 · E-Z-Em, Inc. · Gastroenterology & Urology device
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Jul 1984
Decision
92d
Days
-
Risk

K841720 is an FDA 510(k) clearance for the E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by E-Z-Em, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1984 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all E-Z-Em, Inc. devices

Submission Details

510(k) Number K841720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1984
Decision Date July 26, 1984
Days to Decision 92 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
38d faster than avg
Panel avg: 130d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

All 55
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