Cleared Traditional

K940550 - COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH

K940550 is an FDA 510(k) clearance for COOK BRACH NEEDLE/RADIO DELIV CATH/FLEX..., manufactured by Cook, Inc.. The device is a Class 1 Radiology device with product code IWJ cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K940550 · Cook, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K940550

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 107d · This submission: 191d
Pathway characteristics
Predicate-based equivalence.

IWJ Device Classification - Class 1, General Controls

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.

Regulatory Peers - IWJ System, Applicator, Radionuclide, Manual

All 22
Devices cleared under the same product code (IWJ) and FDA review panel - the closest regulatory comparables to K940550.
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