Cleared Traditional

K920575 - MERKUR 4000

K920575 is an FDA 510(k) clearance for MERKUR 4000, manufactured by F.M. Wiest USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K920575 · F.M. Wiest USA, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 1992
Decision
167d
Days
Class 2
Risk

K920575 is an FDA 510(k) clearance for the MERKUR 4000. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by F.M. Wiest USA, Inc. (Oradell, US). The FDA issued a Cleared decision on July 23, 1992 after a review of 167 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 F.M. Wiest USA, Inc. devices

FDA 510(k) Submission Details - K920575

510(k) Number K920575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1992
Decision Date July 23, 1992
Days to Decision 167 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 131d · This submission: 167d
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 40
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K920575.
UROLAB SPECTRUM
K931179 · Life-Tech Intl., Inc. · Nov 1993
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO
K924383 · Synectics-Dantec · Jun 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