Cleared Traditional

K873178 - URETERAL BULB DILATORS

K873178 is an FDA 510(k) clearance for URETERAL BULB DILATORS, manufactured by Penn Medical Devices, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZN cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K873178 · Penn Medical Devices, Inc. · Gastroenterology & Urology device
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Sep 1987
Decision
49d
Days
Class 2
Risk

K873178 is an FDA 510(k) clearance for the URETERAL BULB DILATORS. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Penn Medical Devices, Inc. (Basking Ridge, US). The FDA issued a Cleared decision on September 30, 1987 after a review of 49 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 Penn Medical Devices, Inc. devices

FDA 510(k) Submission Details - K873178

510(k) Number K873178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1987
Decision Date September 30, 1987
Days to Decision 49 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
81d faster than avg
Panel avg: 130d · This submission: 49d
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 44
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K873178.
ACCENT DG BALLOON URETERAL DILATOR SET
K905375 · Cook Urological, Inc. · Apr 1991
URETERAL BALLOON DILATATION CATHETER
K903813 · Boston Scientific Corp · Nov 1990
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 DILATOR/SHEATH SET
K852793 · American Edwards Laboratories · Aug 1985