Cleared Traditional

K141336 - SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS

K141336 is an FDA 510(k) clearance for SOURCE GUIDE TUBE WITH LOCKING MECHANIS..., manufactured by Varian Medical Systems, Inc.. The device is a Class 2 Radiology device with product code JAQ cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K141336 · Varian Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
77d
Days
Class 2
Risk

K141336 is an FDA 510(k) clearance for the SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on August 6, 2014 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - 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 Varian Medical Systems, Inc. devices

FDA 510(k) Submission Details - K141336

510(k) Number K141336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2014
Decision Date August 06, 2014
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 107d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAQ Device Classification - Class 2, Special Controls

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAQ System, Applicator, Radionuclide, Remote-controlled

All 171
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K141336.
Martinez Prostate Template Set
K142439 · Nucletron B.V. · Mar 2015
Vienna System
K142597 · Mick Radio-Nuclear Instruments, Inc. · Feb 2015
UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET
K141490 · Varian Medical Systems, Inc. · Sep 2014
LUNERAY
K140803 · Nucletron B.V. · Jun 2014
GENTLECARE AR APPLICATOR
K133922 · Gc Medtech, LLC · Apr 2014
KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET
K130757 · Spencer Fillmore · Apr 2014