Cleared Traditional

K973184 - PROSTATE SEEDING NEEDLE

K973184 is an FDA 510(k) clearance for PROSTATE SEEDING NEEDLE, manufactured by Promex, Inc.. The device is a Class 1 Radiology device with product code IWJ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K973184 · Promex, Inc. · Radiology device
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Nov 1997
Decision
88d
Days
Class 1
Risk

K973184 is an FDA 510(k) clearance for the PROSTATE SEEDING NEEDLE. Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by Promex, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 21, 1997 after a review of 88 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 Promex, Inc. devices

FDA 510(k) Submission Details - K973184

510(k) Number K973184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1997
Decision Date November 21, 1997
Days to Decision 88 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
19d faster than avg
Panel avg: 107d · This submission: 88d
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 15
Devices cleared under the same product code (IWJ) and FDA review panel - the closest regulatory comparables to K973184.
MANAN PROSTATE UNI-LOCK
K963743 · Manan Medical Products, Inc. · Dec 1996
MANAN PROSTATE LOCKING INTRODUCER SET
K961377 · Manan Medical Products, Inc. · Jul 1996
MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT
K944522 · Medical Device Technologies, Inc. · Feb 1995
COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH
K940550 · Cook, Inc. · Aug 1994
QUICK SEEDER
K913293 · Mick Radio-Nuclear Instruments, Inc. · Oct 1992
WANG FRONT LOADING APPLICATOR
K890485 · Mick Radio-Nuclear Instruments, Inc. · Apr 1989