Cleared Traditional

NEPHROSTOMY/BILIARY DRAINAGE BAG (K834476) - FDA 510(k) Clearance

K834476 · Vertex Medical Corp. · Gastroenterology & Urology device
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Feb 1984
Decision
46d
Days
-
Risk

K834476 is an FDA 510(k) clearance for the NEPHROSTOMY/BILIARY DRAINAGE BAG. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Vertex Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 46 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vertex Medical Corp. devices

Submission Details

510(k) Number K834476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1983
Decision Date February 04, 1984
Days to Decision 46 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
84d faster than avg
Panel avg: 130d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -