Cleared Traditional

PERCUTANEOUS GRAINAGE CATHETER (K943893) - FDA 510(k) Clearance

K943893 · Menlo Care, Inc. · Gastroenterology & Urology device
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Mar 1995
Decision
210d
Days
-
Risk

K943893 is an FDA 510(k) clearance for the PERCUTANEOUS GRAINAGE CATHETER. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Menlo Care, Inc. (Menlo Park, US). The FDA issued a Cleared decision on March 7, 1995 after a review of 210 days - an extended review cycle.

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.

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Submission Details

510(k) Number K943893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1994
Decision Date March 07, 1995
Days to Decision 210 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 130d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -