Cleared Traditional

K920777 - LABORIE URODYNAMICS PROCESSOR

K920777 is an FDA 510(k) clearance for LABORIE URODYNAMICS PROCESSOR, manufactured by R. Laborie Surgical , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K920777 · R. Laborie Surgical , Ltd. · Gastroenterology & Urology device
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Sep 1992
Decision
197d
Days
Class 2
Risk

K920777 is an FDA 510(k) clearance for the LABORIE URODYNAMICS PROCESSOR. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by R. Laborie Surgical , Ltd. (North Attleboro, US). The FDA issued a Cleared decision on September 4, 1992 after a review of 197 days - an extended review cycle.

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 R. Laborie Surgical , Ltd. devices

FDA 510(k) Submission Details - K920777

510(k) Number K920777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1992
Decision Date September 04, 1992
Days to Decision 197 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
67d slower than avg
Panel avg: 130d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAP Device Classification - Class 2, Special Controls

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 25
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K920777.
RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
K962472 · Rusch Intl. · Aug 1996
UROLAB SPECTRUM
K931179 · Life-Tech Intl., Inc. · Nov 1993
ENDOTEK ULTRA SYSTEM
K920451 · Surgitek · Sep 1992
URETHRALPRESSURE PROFILE CATHETER
K915484 · Life-Tech Intl., Inc. · Feb 1992
URODYNAMIC CATHETER
K915443 · Cook Urological, Inc. · Feb 1992
DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST
K913736 · Biosearch Medical Products, Inc. · Feb 1992