Cleared Traditional

K884711 - URETHRAL AND URETERAL BALLOON DILATATORS

K884711 is an FDA 510(k) clearance for URETHRAL AND URETERAL BALLOON DILATATORS, manufactured by Primrose Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZN cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K884711 · Primrose Medical, Inc. · Gastroenterology & Urology device
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Sep 1989
Decision
325d
Days
Class 2
Risk

K884711 is an FDA 510(k) clearance for the URETHRAL AND URETERAL BALLOON DILATATORS. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Primrose Medical, Inc. (Woburn, US). The FDA issued a Cleared decision on September 29, 1989 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Primrose Medical, Inc. devices

FDA 510(k) Submission Details - K884711

510(k) Number K884711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1988
Decision Date September 29, 1989
Days to Decision 325 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
194d slower than avg
Panel avg: 131d · This submission: 325d
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 52
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K884711.
URETERAL BALLOON DILATATION CATHETER
K903813 · Boston Scientific Corp · Nov 1990
BALLOON DILATION CATHETER
K896448 · Cook Ob/Gyn · Mar 1990
AMCATH URETERAL DILATORS MODELS 7100,7110,7120
K894925 · Intec Medical, Inc. · Dec 1989
VAN-TEC ONE STEP URETERAL DILATATION CATHETER
K870697 · Van-Tec, Inc. · Mar 1987
URETERAL DILATOR
K852324 · American Edwards Laboratories · Aug 1985
URETERAL DILATOR/SHEATH SET
K852793 · American Edwards Laboratories · Aug 1985