Cleared Traditional

K924128 - CHOLANGIOGRAPHY CATHETER

K924128 is an FDA 510(k) clearance for CHOLANGIOGRAPHY CATHETER, manufactured by Applied Medical Resources. The device is a Class 1 General & Plastic Surgery device with product code GBZ cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K924128 · Applied Medical Resources · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
177d
Days
Class 1
Risk

K924128 is an FDA 510(k) clearance for the CHOLANGIOGRAPHY CATHETER. Classified as Catheter, Cholangiography (product code GBZ), Class I - General Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on February 10, 1993 after a review of 177 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 Applied Medical Resources devices

FDA 510(k) Submission Details - K924128

510(k) Number K924128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1992
Decision Date February 10, 1993
Days to Decision 177 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 115d · This submission: 177d
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 16
Devices cleared under the same product code (GBZ) and FDA review panel - the closest regulatory comparables to K924128.
ANGIOLAPCATH CHOLANGIOGRAPHY KIT
K926143 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1993
CLARUS CHOLANGIOGRAM CATHETER KIT
K925742 · Clarus Medical Systems, Inc. · Jun 1993
CHOLANGIOGRAPHY CLAMP
K924480 · Applied Medical Resources · Mar 1993
LAPAROSCOPIC SUCTION/IRRIGATION PROBE
K920643 · O.R. Concepts, Inc. · May 1992
CHOLANGIOLAPCATH(TM)
K921091 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1992
CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP
K914015 · Pilling Co. · Nov 1991