Cleared Traditional

K923738 - HIGH DOSE RATE REMOTE AFTERLOADING CATHETER

K923738 is an FDA 510(k) clearance for HIGH DOSE RATE REMOTE AFTERLOADING CATHETER, manufactured by Cook, Inc.. The device is a Class 2 Radiology device with product code JAQ cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K923738 · Cook, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
260d
Days
Class 2
Risk

K923738 is an FDA 510(k) clearance for the HIGH DOSE RATE REMOTE AFTERLOADING CATHETER. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on April 13, 1993 after a review of 260 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - 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.

FDA 510(k) Submission Details - K923738

510(k) Number K923738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1992
Decision Date April 13, 1993
Days to Decision 260 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
153d slower than avg
Panel avg: 107d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAQ Device Classification - Class 2, Special Controls

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAQ System, Applicator, Radionuclide, Remote-controlled

All 207
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K923738.
HIGH DOSE RATE AFTERLOADER
K945383 · Varian Assoc., Inc. · Feb 1995
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MICROSELECTRON - HDR FOR MOBILE ENVIRONMENT
K925956 · Nucletron-Oldelft Corp. · Nov 1993
6 FRENCH CATHETER
K922564 · S. and H. Engineering, Inc. · Dec 1992
PULMOCATH INTRABRONCHIAL CATHETER
K901615 · Omnitron Intl., Inc. · Nov 1992
PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM
K915622 · Nucletron-Oldelft Corp. · Sep 1992
K923738 · HIGH DOSE RATE REMOTE AFTERLOADING CATHETER
Download PDF FDA Summary Cook, Inc.