Cleared Traditional

K963743 - MANAN PROSTATE UNI-LOCK

K963743 is an FDA 510(k) clearance for MANAN PROSTATE UNI-LOCK, manufactured by Manan Medical Products, Inc.. The device is a Class 1 Radiology device with product code IWJ cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K963743 · Manan Medical Products, Inc. · Radiology device
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Dec 1996
Decision
80d
Days
Class 1
Risk

K963743 is an FDA 510(k) clearance for the MANAN PROSTATE UNI-LOCK. Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by Manan Medical Products, Inc. (Northbrook, US). The FDA issued a Cleared decision on December 6, 1996 after a review of 80 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 Manan Medical Products, Inc. devices

FDA 510(k) Submission Details - K963743

510(k) Number K963743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1996
Decision Date December 06, 1996
Days to Decision 80 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 107d · This submission: 80d
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 K963743.
NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE
K973786 · Nw Radiation Therapy Products · Jan 1998
N.I.T., INC. NEEDLE GUIDING TEMPLATE
K973638 · Avid N.I.T., Inc. · Dec 1997
PROSTATE SEEDING NEEDLE
K973184 · Promex, Inc. · Nov 1997
WEEKS APPLICATOR
K951052 · Duke University Medical Center · Aug 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