Cleared Traditional

K926143 - ANGIOLAPCATH CHOLANGIOGRAPHY KIT

K926143 is an FDA 510(k) clearance for ANGIOLAPCATH CHOLANGIOGRAPHY KIT, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 General & Plastic Surgery device with product code GBZ cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K926143 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
212d
Days
Class 1
Risk

K926143 is an FDA 510(k) clearance for the ANGIOLAPCATH CHOLANGIOGRAPHY KIT. Classified as Catheter, Cholangiography (product code GBZ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on July 7, 1993 after a review of 212 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K926143

510(k) Number K926143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 07, 1992
Decision Date July 07, 1993
Days to Decision 212 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
97d slower than avg
Panel avg: 115d · This submission: 212d
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 17
Devices cleared under the same product code (GBZ) and FDA review panel - the closest regulatory comparables to K926143.
MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER
K932228 · Boston Scientific Corp · Aug 1993
TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE
K926217 · Terumo Medical Corp. · Jul 1993
STRYKER ENDOSCOPY CHOLANGIOGRAM KIT
K924212 · Stryker Corp. · Jul 1993
CLARUS CHOLANGIOGRAM CATHETER KIT
K925742 · Clarus Medical Systems, Inc. · Jun 1993
CHOLANGIOGRAPHY CLAMP
K924480 · Applied Medical Resources · Mar 1993
CHOLANGIOGRAPHY CATHETER
K924128 · Applied Medical Resources · Feb 1993