Cleared Traditional

K871216 - HILARIS-NORI ENDOMETRIAL APPLICATOR

K871216 is an FDA 510(k) clearance for HILARIS-NORI ENDOMETRIAL APPLICATOR, 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 117-day FDA review.

K871216 · Mick Radio-Nuclear Instruments, Inc. · Radiology device
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Jul 1987
Decision
117d
Days
Class 1
Risk

K871216 is an FDA 510(k) clearance for the HILARIS-NORI ENDOMETRIAL APPLICATOR. Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by Mick Radio-Nuclear Instruments, Inc. (Bronx, US). The FDA issued a Cleared decision on July 21, 1987 after a review of 117 days - within the typical 510(k) review window.

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 Mick Radio-Nuclear Instruments, Inc. devices

FDA 510(k) Submission Details - K871216

510(k) Number K871216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1987
Decision Date July 21, 1987
Days to Decision 117 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
10d slower than avg
Panel avg: 107d · This submission: 117d
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 K871216.
HILARIS-NORI CERVIX APPLICATOR
K891377 · Mick Radio-Nuclear Instruments, Inc. · Apr 1989
MICK 200-TP AND MICK TP NEEDLE
K890341 · Mick Radio-Nuclear Instruments, Inc. · Mar 1989
HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN
K890191 · Amersham Corp. · Feb 1989
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