Cleared Traditional

K833762 - PERCUTANEOUS RETROGRADE NEPHROSTOMY

K833762 · Vpi · Gastroenterology & Urology device
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Feb 1984
Decision
107d
Days
-
Risk

K833762 is an FDA 510(k) clearance for the PERCUTANEOUS RETROGRADE NEPHROSTOMY. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Vpi (Walker, US). The FDA issued a Cleared decision on February 10, 1984 after a review of 107 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.

FDA 510(k) Submission Details - K833762

510(k) Number K833762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1983
Decision Date February 10, 1984
Days to Decision 107 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
24d faster than avg
Panel avg: 131d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

LJE Device Classification - Class 0,

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

All 54
Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K833762.
E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE
K842121 · E-Z-Em, Inc. · Oct 1984
CURITY SUPRAPUBIC DRAINAGE SYSTEM
K842899 · The Kendal Co. · Sep 1984
E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS
K841720 · E-Z-Em, Inc. · Jul 1984
NEPHROSTOMY/BILIARY DRAINAGE BAG
K834476 · Vertex Medical Corp. · Feb 1984
PERCUTANEOUS NEPHROSTOMY CATHETER
K833008 · Medical Engineering Corp. · Oct 1983
URINARY DIVERSION STENT
K830803 · Van-Tec, Inc. · May 1983