Cleared Traditional

K960143 - G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY

K960143 is an FDA 510(k) clearance for G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY, manufactured by GE Medical Systems. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K960143 · GE Medical Systems · Cardiovascular device
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Apr 1996
Decision
84d
Days
Class 1
Risk

K960143 is an FDA 510(k) clearance for the G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by GE Medical Systems (Palm Harbor, US). The FDA issued a Cleared decision on April 9, 1996 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all GE Medical Systems devices

FDA 510(k) Submission Details - K960143

510(k) Number K960143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received January 16, 1996
Decision Date April 09, 1996
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

DWS Device Classification - Class 1, General Controls

Product Code DWS Instruments, Surgical, Cardiovascular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
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 - DWS Instruments, Surgical, Cardiovascular

All 41
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K960143.
OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)
K964445 · Dlp, Inc. · Jan 1997
G.E. STERILE ANGIOGRAPHIC TRAY
K960139 · GE Medical Systems · Apr 1996
G.E. STERILE CT BIOPSY TRAY
K960144 · GE Medical Systems · Apr 1996
REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER
K934727 · Cardiac Pacemakers, Inc. · Jan 1994
HYCULT DIAMOND CORONARY BYPASS KNIFE
K900379 · St. Jude Medical, Inc. · Mar 1990
INSULATION PAD
K896307 · Bio-Vascular, Inc. · Jan 1990