Cleared Traditional

K080791 - CONTURA MULTI-LUMEN BALLOON SOURCE APPL...

K080791 is the FDA 510(k) clearance for CONTURA MULTI-LUMEN BALLOON SOURCE APPL... by Senorx, Inc.. It is a Class 2 Radiology device (product code JAQ) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K080791 · Senorx, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
41d
Days
Class 2
Risk

K080791 is an FDA 510(k) clearance for the CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-.... Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Senorx, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on April 30, 2008 after a review of 41 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 Senorx, Inc. devices

Submission Details

510(k) Number K080791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received March 20, 2008
Decision Date April 30, 2008
Days to Decision 41 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 107d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 101
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K080791.
MAMMOSITE II RADIATION THERAPY SYSTEM
K091378 · Hologic, Inc. · Jul 2009
CENTERING INTRALUMINAL APPLICATOR
K082653 · Varian Medical Systems, Inc. · Oct 2008
MAMMOSITE CAVITY EVALUATION DEVICE
K081179 · Hologic, Inc. · May 2008
INTERSTITIAL NEEDLES
K073133 · Varian Medical Systems, Inc. · Nov 2007
GAMMAMEDPLUS IX SERIES HDR AFTERLOADER
K071381 · Varian Medical Systems · Jul 2007
VARISOURCE IX HDR AFTERLOADER
K071467 · Varian Medical Systems, Inc. · Jul 2007