Cleared Traditional

K890191 - HANDLING & CUTTING DEVICE FOR IRIDIUM-1...

K890191 is the FDA 510(k) clearance for HANDLING & CUTTING DEVICE FOR IRIDIUM-1... by Amersham Corp.. It is a Class 1 Radiology device (product code IWJ) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K890191 · Amersham Corp. · Radiology device
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Feb 1989
Decision
19d
Days
Class 1
Risk

K890191 is an FDA 510(k) clearance for the HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN. Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on February 6, 1989 after a review of 19 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 Amersham Corp. devices

Submission Details

510(k) Number K890191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1989
Decision Date February 06, 1989
Days to Decision 19 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 107d · This submission: 19d
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.

Regulatory Peers - IWJ System, Applicator, Radionuclide, Manual

All 14
Devices cleared under the same product code (IWJ) and FDA review panel - the closest regulatory comparables to K890191.
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K871213 · Mick Radio-Nuclear Instruments, Inc. · Jul 1987
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