Cleared Traditional

K132383 - GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER (FDA 510(k) Clearance)

K132383 · Gyrus Acmi, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Feb 2014
Decision
188d
Days
-
Risk

K132383 is an FDA 510(k) clearance for the GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on February 4, 2014 after a review of 188 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.

View all Gyrus Acmi, Inc. devices

Submission Details

510(k) Number K132383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2013
Decision Date February 04, 2014
Days to Decision 188 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 130d · This submission: 188d
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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