Cleared Traditional

K890341 - MICK 200-TP AND MICK TP NEEDLE (FDA 510(k) Clearance)

Class I Radiology device.

K890341 · Mick Radio-Nuclear Instruments, Inc. · Radiology device
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Mar 1989
Decision
50d
Days
Class 1
Risk

K890341 is an FDA 510(k) clearance for the MICK 200-TP AND MICK TP NEEDLE. Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by Mick Radio-Nuclear Instruments, Inc. (Bronx, US). The FDA issued a Cleared decision on March 14, 1989 after a review of 50 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mick Radio-Nuclear Instruments, Inc. devices

Submission Details

510(k) Number K890341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1989
Decision Date March 14, 1989
Days to Decision 50 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 107d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.