Cleared Traditional

K921886 - NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE (FDA 510(k) Clearance)

Class I Radiology device.

K921886 · Needle Technologies, Inc. · Radiology device
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Oct 1992
Decision
167d
Days
Class 1
Risk

K921886 is an FDA 510(k) clearance for the NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE. Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by Needle Technologies, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on October 5, 1992 after a review of 167 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Needle Technologies, Inc. devices

Submission Details

510(k) Number K921886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1992
Decision Date October 05, 1992
Days to Decision 167 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
60d slower than avg
Panel avg: 107d · This submission: 167d
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.