Cleared Traditional

K933410 - IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES (FDA 510(k) Clearance)

Class I Radiology device.

K933410 · Best Industries · Radiology device
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Dec 1994
Decision
533d
Days
Class 1
Risk

K933410 is an FDA 510(k) clearance for the IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT O.... Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by Best Industries (Springfield, US). The FDA issued a Cleared decision on December 30, 1994 after a review of 533 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

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Submission Details

510(k) Number K933410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1993
Decision Date December 30, 1994
Days to Decision 533 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
426d slower than avg
Panel avg: 107d · This submission: 533d
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.