Cleared Traditional

URINARY DIVERSION STENT (K830803) - FDA 510(k) Clearance

K830803 · Van-Tec, Inc. · Gastroenterology & Urology device
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May 1983
Decision
52d
Days
-
Risk

K830803 is an FDA 510(k) clearance for the URINARY DIVERSION STENT. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Van-Tec, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 5, 1983 after a review of 52 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 Van-Tec, Inc. devices

Submission Details

510(k) Number K830803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1983
Decision Date May 05, 1983
Days to Decision 52 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
78d faster than avg
Panel avg: 130d · This submission: 52d
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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