Cleared Special

K093291 - VARIAN INTERSTITIAL TITANIUM NEEDLES

K093291 is an FDA 510(k) clearance for VARIAN INTERSTITIAL TITANIUM NEEDLES, manufactured by Varian Medical Systems, Inc.. The device is a Class 2 Radiology device with product code JAQ cleared through the Special 510(k) pathway after a 27-day FDA review.

K093291 · Varian Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
27d
Days
Class 2
Risk

K093291 is an FDA 510(k) clearance for the VARIAN INTERSTITIAL TITANIUM NEEDLES. 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 November 17, 2009 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Varian Medical Systems, Inc. devices

FDA 510(k) Submission Details - K093291

510(k) Number K093291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2009
Decision Date November 17, 2009
Days to Decision 27 days
Submission Type Special
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
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 172
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K093291.
CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN
K113766 · Varian Medical Systems, Inc. · Mar 2012
ONCENTRA PROSTATE 4.0
K112420 · Nucletron · Nov 2011
VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET
K111973 · Nucletron · Sep 2011
MICROSELECTRON HDR V2, MODEL 105.999
K092804 · Nucletron Corp. · Oct 2009
MAMMOSITE MULTI LUMEN
K092405 · Hologic, Inc. · Aug 2009
CONTURA CAVITY MAINTENANCE CATHETER
K092323 · Senorx, Inc. · Aug 2009