Cleared Traditional

K923394 - MENLO CARE AQUASTENT SET

K923394 is the FDA 510(k) clearance for MENLO CARE AQUASTENT SET by Menlo Care, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Traditional 510(k) pathway after a 494-day FDA review.

K923394 · Menlo Care, Inc. · Gastroenterology & Urology device
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Nov 1993
Decision
494d
Days
Class 2
Risk

K923394 is an FDA 510(k) clearance for the MENLO CARE AQUASTENT SET. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Menlo Care, Inc. (Menlo Park, US). The FDA issued a Cleared decision on November 16, 1993 after a review of 494 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4620 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Menlo Care, Inc. devices

Submission Details

510(k) Number K923394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1992
Decision Date November 16, 1993
Days to Decision 494 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
364d slower than avg
Panel avg: 130d · This submission: 494d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAD Stent, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4620
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 - FAD Stent, Ureteral

All 77
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K923394.
CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT
K960148 · Cabot Medical Corp. · Mar 1996
SLIP-COAT STENTS
K930731 · Cook Urological, Inc. · Dec 1994
MENLO CARE URINARY DIVERSION STENT
K933941 · Menlo Care, Inc. · Mar 1994
UROLOGICAL CATHETER & ACCESSORIES
K930882 · Applied Medical Resources · Jul 1993
ECHOSIGHT STENT SET
K914280 · Cook Urological, Inc. · Jan 1992
MENTOR BLACK LIGHT INJECTION STENT SET
K912060 · Mentor Corp. · Sep 1991