Cleared Traditional

K925742 - CLARUS CHOLANGIOGRAM CATHETER KIT (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K925742 · Clarus Medical Systems, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jun 1993
Decision
200d
Days
Class 1
Risk

K925742 is an FDA 510(k) clearance for the CLARUS CHOLANGIOGRAM CATHETER KIT. Classified as Catheter, Cholangiography (product code GBZ), Class I - General Controls.

Submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 1, 1993 after a review of 200 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Clarus Medical Systems, Inc. devices

Submission Details

510(k) Number K925742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 13, 1992
Decision Date June 01, 1993
Days to Decision 200 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 114d · This submission: 200d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBZ Catheter, Cholangiography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.