Cleared Traditional

K903403 - CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR

K903403 is an FDA 510(k) clearance for CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR, manufactured by University of Michigan. The device is a Class 1 Radiology device with product code IWJ cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K903403 · University of Michigan · Radiology device
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Oct 1990
Decision
62d
Days
Class 1
Risk

K903403 is an FDA 510(k) clearance for the CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR. Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by University of Michigan (Ann Arbor, US). The FDA issued a Cleared decision on October 1, 1990 after a review of 62 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.

FDA 510(k) Submission Details - K903403

510(k) Number K903403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date October 01, 1990
Days to Decision 62 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
45d faster than avg
Panel avg: 107d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

IWJ Device Classification - Class 1, General Controls

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 31
Devices cleared under the same product code (IWJ) and FDA review panel - the closest regulatory comparables to K903403.
QUICK SEEDER
K913293 · Mick Radio-Nuclear Instruments, Inc. · Oct 1992
VARIOUS TEMPLATE APPLICATORS
K910862 · Best Industries · Apr 1991
VARIOUS AFTERLOADING APPLICATORS
K904933 · Best Assoc. Corp. · Jan 1991
PLASTIC-GUIDES
K901842 · M & K Co. · Jul 1990
AFTER LOADING DEVICE KIT
K893703 · Medical Radiation Devices, Inc. · Sep 1989
WANG FRONT LOADING APPLICATOR
K890485 · Mick Radio-Nuclear Instruments, Inc. · Apr 1989
K903403 · CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR
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