Cleared Special

PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 (K092136) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K092136 · Isoray Medical, Inc. · Radiology device
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Aug 2009
Decision
23d
Days
Class 2
Risk

K092136 is an FDA 510(k) clearance for the PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Isoray Medical, Inc. (Richland, US). The FDA issued a Cleared decision on August 7, 2009 after a review of 23 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.

View all Isoray Medical, Inc. devices

Submission Details

510(k) Number K092136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2009
Decision Date August 07, 2009
Days to Decision 23 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 150
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