Cleared Special

K003270 - PROSTATE STEPPER TEMPLATE SET

K003270 is the FDA 510(k) clearance for PROSTATE STEPPER TEMPLATE SET by Nucletron Corp.. It is a Class 2 Radiology device (product code JAQ) cleared through the Special 510(k) pathway after a 65-day FDA review.

K003270 · Nucletron Corp. · Radiology device
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Dec 2000
Decision
65d
Days
Class 2
Risk

K003270 is an FDA 510(k) clearance for the PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Nucletron Corp. (Columbia, US). The FDA issued a Cleared decision on December 22, 2000 after a review of 65 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K003270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2000
Decision Date December 22, 2000
Days to Decision 65 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
42d faster than avg
Panel avg: 107d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 121
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