Cleared Traditional

K832808 - URETERAL DILATION SET

K832808 is an FDA 510(k) clearance for URETERAL DILATION SET, manufactured by Van-Tec, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZN cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K832808 · Van-Tec, Inc. · Gastroenterology & Urology device
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Oct 1983
Decision
57d
Days
Class 2
Risk

K832808 is an FDA 510(k) clearance for the URETERAL DILATION SET. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Van-Tec, Inc. (Walker, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5470 - the FDA gastroenterology and urology device framework. 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

FDA 510(k) Submission Details - K832808

510(k) Number K832808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1983
Decision Date October 14, 1983
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 131d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZN Device Classification - Class 2, Special Controls

Product Code EZN Dilator, Catheter, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5470
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - EZN Dilator, Catheter, Ureteral

All 51
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K832808.
DILATOR/SHEATH SET
K842632 · American Edwards Laboratories · Oct 1984
AMER. EDWARDS LAB DIAFLEX URETERAL DILA
K842639 · American Edwards Laboratories · Oct 1984
VAN-TEC URETERAL DILATION BALLOON CATH
K841940 · Van-Tec, Inc. · Aug 1984
VPI URETERAL DILATATION BALLON CATHETER
K813278 · Vance Products, Inc. · Dec 1981