Cleared Traditional

K936041 - UROGRAM CYSTOMETROGRAM

K936041 is an FDA 510(k) clearance for UROGRAM CYSTOMETROGRAM, manufactured by Myo/Kinetic Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FEN cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K936041 · Myo/Kinetic Systems, Inc. · Gastroenterology & Urology device
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Apr 1994
Decision
119d
Days
Class 2
Risk

K936041 is an FDA 510(k) clearance for the UROGRAM CYSTOMETROGRAM. Classified as Device, Cystometric, Hydraulic (product code FEN), Class II - Special Controls.

Submitted by Myo/Kinetic Systems, Inc. (Menomonee Falls, US). The FDA issued a Cleared decision on April 18, 1994 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - 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 Myo/Kinetic Systems, Inc. devices

FDA 510(k) Submission Details - K936041

510(k) Number K936041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1993
Decision Date April 18, 1994
Days to Decision 119 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 130d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEN Device Classification - Class 2, Special Controls

Product Code FEN Device, Cystometric, Hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
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 - FEN Device, Cystometric, Hydraulic

All 13
Devices cleared under the same product code (FEN) and FDA review panel - the closest regulatory comparables to K936041.
RUSCH URODYNAMIC RECTAL BALLOON CATHETER
K952573 · Rusch Intl. · Jun 1995
RUSCH INTERNATIONAL URODYNAMIC CATHETERS
K952029 · Rusch Intl. · Jun 1995
OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM
K944391 · Surgitek · Feb 1995
TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS
K940203 · Life-Tech Intl., Inc. · Mar 1994
STAND ALONE CYSTOMETROGRAM
K934141 · Medical Engineering Corp. · Nov 1993
KENDALL URODYNAMIC CATHETERS
K933399 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1993