Cleared Special

K043596 - THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06

K043596 is an FDA 510(k) clearance for THERALOAD CUSTOM LOADED NEEDLES, manufactured by Theragenics Corp.. The device is a Class 2 Radiology device with product code KXK cleared through the Special 510(k) pathway after a 28-day FDA review.

K043596 · Theragenics Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
28d
Days
Class 2
Risk

K043596 is an FDA 510(k) clearance for the THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Theragenics Corp. (Buford, US). The FDA issued a Cleared decision on January 26, 2005 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K043596

510(k) Number K043596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2004
Decision Date January 26, 2005
Days to Decision 28 days
Submission Type Special
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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

KXK Device Classification - Class 2, Special Controls

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
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 - KXK Source, Brachytherapy, Radionuclide

All 145
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K043596.
CURAY CUSTOM SEED ARRAY
K053595 · Biolucent, Inc. · Feb 2006
NSTRAND IMPLANTATION KIT
K052024 · North American Scientific, Inc. · Sep 2005
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
K043246 · C.R. Bard, Inc. · Feb 2005
OPTISTRAND, MODEL 1032S
K043336 · Ibt SA · Jan 2005
IMPLANT SCIENCES CORP, MODEL HDR-4140
K042864 · Implant Sciences Corp. · Jan 2005
BEST RADIOPAQUE STRAND
K043117 · Best Medical International, Inc. · Dec 2004
K043596 · THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06
Download PDF FDA Summary Theragenics Corp.