Cleared Traditional

K925742 - CLARUS CHOLANGIOGRAM CATHETER KIT

K925742 is an FDA 510(k) clearance for CLARUS CHOLANGIOGRAM CATHETER KIT, manufactured by Clarus Medical Systems, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBZ cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K925742 · Clarus Medical Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K925742

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
85d slower than avg
Panel avg: 115d · This submission: 200d
Pathway characteristics
Predicate-based equivalence.

GBZ Device Classification - Class 1, General Controls

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.

Regulatory Peers - GBZ Catheter, Cholangiography

All 13
Devices cleared under the same product code (GBZ) and FDA review panel - the closest regulatory comparables to K925742.
TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE
K926217 · Terumo Medical Corp. · Jul 1993
STRYKER ENDOSCOPY CHOLANGIOGRAM KIT
K924212 · Stryker Corp. · Jul 1993
ANGIOLAPCATH CHOLANGIOGRAPHY KIT
K926143 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1993
CHOLANGIOGRAPHY CLAMP
K924480 · Applied Medical Resources · Mar 1993
CHOLANGIOGRAPHY CATHETER
K924128 · Applied Medical Resources · Feb 1993
LAPAROSCOPIC SUCTION/IRRIGATION PROBE
K920643 · O.R. Concepts, Inc. · May 1992