Cleared Traditional

K921839 - ENTRAC URETERAL BALLOON DILATION CATHETERS

K921839 is the FDA 510(k) clearance for ENTRAC URETERAL BALLOON DILATION CATHETERS by American Medical Systems, Inc.. It is a Class 2 Gastroenterology & Urology device (product code EZN) cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K921839 · American Medical Systems, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Oct 1992
Decision
194d
Days
Class 2
Risk

K921839 is an FDA 510(k) clearance for the ENTRAC URETERAL BALLOON DILATION CATHETERS. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by American Medical Systems, Inc. (Minnetonka, US). The FDA issued a Cleared decision on October 28, 1992 after a review of 194 days - an extended review 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: 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.

View all American Medical Systems, Inc. devices

Submission Details

510(k) Number K921839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1992
Decision Date October 28, 1992
Days to Decision 194 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 130d · This submission: 194d
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 K921839.
NAMIC ARIA(TM) INFLATION DEVICE
K940542 · American Medical Systems, Inc. · Apr 1994
UROLOGICAL BALLOON DILATATION CATHETER
K935379 · Boston Scientific Corp · Feb 1994
MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER
K933011 · Boston Scientific Corp · Feb 1994
UROLOGICAL BALLOON DILATATION CATHETER
K920946 · Boston Scientific Corp · Jul 1992
ACCENT DG BALLOON URTERAL DILATOR SET, 10CM
K915392 · Cook Urological, Inc. · Mar 1992
CATHETER, URETERAL DILATOR
K914617 · Boston Scientific Corp · Dec 1991