Cleared Traditional

K940550 - COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH (FDA 510(k) Clearance)

Class I Radiology device.

K940550 · Cook, Inc. · Radiology device
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Aug 1994
Decision
191d
Days
Class 1
Risk

K940550 is an FDA 510(k) clearance for the COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH. Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on August 17, 1994 after a review of 191 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5650 - the FDA radiology and imaging software 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook, Inc. devices

Submission Details

510(k) Number K940550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1994
Decision Date August 17, 1994
Days to Decision 191 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 107d · This submission: 191d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWJ System, Applicator, Radionuclide, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.5650
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.