Cleared Traditional

K900494 - SYNECTICS LIBERTY SYSTEM

K900494 is the FDA 510(k) clearance for SYNECTICS LIBERTY SYSTEM by Synectics-Dantec. It is a Class 2 Gastroenterology & Urology device (product code FAP) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K900494 · Synectics-Dantec · Gastroenterology & Urology device
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Jun 1990
Decision
129d
Days
Class 2
Risk

K900494 is an FDA 510(k) clearance for the SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Synectics-Dantec (Irving, US). The FDA issued a Cleared decision on June 11, 1990 after a review of 129 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.

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Submission Details

510(k) Number K900494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1990
Decision Date June 11, 1990
Days to Decision 129 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
1d faster than avg
Panel avg: 130d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device
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 - FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device

All 7
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K900494.
DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST
K913736 · Biosearch Medical Products, Inc. · Feb 1992
URODYNAMIC RECTAL BALLOON
K912451 · Cook Urological, Inc. · Dec 1991
BIOSEARCH ANAL BIOFEEDBACK DEVICE
K902843 · Biosearch Medical Products, Inc. · Sep 1990
URETHRAL PRESSURE PROFILE & TEMP. MODUL
K823561 · Nihon Kohden America, Inc. · Jan 1983
ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2
K790519 · American Medical Systems, Inc. · May 1979
UROFLOW-CYSTOMETER SYSTEM
K771850 · Richard Wolf Medical Instruments Corp. · Oct 1977