Cleared Traditional

K852793 - URETERAL DILATOR/SHEATH SET

K852793 is the FDA 510(k) clearance for URETERAL DILATOR/SHEATH SET by American Edwards Laboratories. It is a Class 2 Gastroenterology & Urology device (product code EZN) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K852793 · American Edwards Laboratories · Gastroenterology & Urology device
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Aug 1985
Decision
39d
Days
Class 2
Risk

K852793 is an FDA 510(k) clearance for the URETERAL DILATOR/SHEATH SET. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on August 9, 1985 after a review of 39 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 American Edwards Laboratories devices

Submission Details

510(k) Number K852793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1985
Decision Date August 09, 1985
Days to Decision 39 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
91d faster than avg
Panel avg: 130d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 43
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K852793.
BALLOON DILATION CATHETER
K896448 · Cook Ob/Gyn · Mar 1990
VAN-TEC ONE STEP URETERAL DILATATION CATHETER
K870697 · Van-Tec, Inc. · Mar 1987
URETERAL DILATOR
K852324 · American Edwards Laboratories · Aug 1985
URETERAL DILATION SET
K851144 · Van-Tec, Inc. · Apr 1985
MENTOR PERCUTANEOUS RENAL DILATOR SET
K850355 · Mentor Corp. · Mar 1985
DIAFLEX NEPHROSTOMY BALLOON DILATOR
K842206 · American Edwards Laboratories · Oct 1984