Cleared Traditional

K801983 - SCOTT NEEDLE & SCOTT MICK IMPLANTER

K801983 is an FDA 510(k) clearance for SCOTT NEEDLE & SCOTT MICK IMPLANTER, manufactured by Mick Radio-Nuclear Instruments, Inc.. The device is a Class 1 Radiology device with product code IWJ cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K801983 · Mick Radio-Nuclear Instruments, Inc. · Radiology device
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Oct 1980
Decision
65d
Days
Class 1
Risk

K801983 is an FDA 510(k) clearance for the SCOTT NEEDLE & SCOTT MICK IMPLANTER. Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by Mick Radio-Nuclear Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 65 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

FDA 510(k) Submission Details - K801983

510(k) Number K801983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1980
Decision Date October 23, 1980
Days to Decision 65 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
42d faster than avg
Panel avg: 107d · This submission: 65d
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 22
Devices cleared under the same product code (IWJ) and FDA review panel - the closest regulatory comparables to K801983.
KUMAR CERVICAL APPLICATOR
K871213 · Mick Radio-Nuclear Instruments, Inc. · Jul 1987
HENSCHKE AFTERLOADING APPLICATOR
K871217 · Mick Radio-Nuclear Instruments, Inc. · Jul 1987
I-125 IMPLANT GUN
K850571 · Mick Radio-Nuclear Instruments, Inc. · Mar 1985
CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.
K800320 · Amersham Corp. · Mar 1980