Cleared Traditional

K933941 - MENLO CARE URINARY DIVERSION STENT

K933941 is an FDA 510(k) clearance for MENLO CARE URINARY DIVERSION STENT, manufactured by Menlo Care, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K933941 · Menlo Care, Inc. · Gastroenterology & Urology device
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Mar 1994
Decision
231d
Days
Class 2
Risk

K933941 is an FDA 510(k) clearance for the MENLO CARE URINARY DIVERSION STENT. 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 March 31, 1994 after a review of 231 days - an extended review cycle.

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: 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 Menlo Care, Inc. devices

FDA 510(k) Submission Details - K933941

510(k) Number K933941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1993
Decision Date March 31, 1994
Days to Decision 231 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
100d slower than avg
Panel avg: 131d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAD Device Classification - Class 2, Special Controls

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 105
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K933941.
QUADRA-COIL URETERAL STENT
K946296 · Surgitek · Mar 1995
SLIP-COAT STENTS
K930731 · Cook Urological, Inc. · Dec 1994
SURGITEK INFUSER
K941952 · Surgitek · May 1994
MENLO CARE AQUASTENT SET
K923394 · Menlo Care, Inc. · Nov 1993
URETERAL STENT
K930733 · Surgitek · Jul 1993
UROLOGICAL CATHETER & ACCESSORIES
K930882 · Applied Medical Resources · Jul 1993