Cleared Traditional

CHOLANGIOGRAPHY CLAMP (K924480) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K924480 · Applied Medical Resources · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
181d
Days
Class 1
Risk

K924480 is an FDA 510(k) clearance for the CHOLANGIOGRAPHY CLAMP. 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 March 3, 1993 after a review of 181 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

Submission Details

510(k) Number K924480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1992
Decision Date March 03, 1993
Days to Decision 181 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
66d slower than avg
Panel avg: 115d · This submission: 181d
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.

Regulatory Peers - GBZ Catheter, Cholangiography

Devices cleared under the same product code (GBZ) and FDA review panel - the closest regulatory comparables to K924480.
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
CHOLANGIOLAPCATH(TM)
K921091 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1992