Cleared Traditional

K063815 - VARIAN ESOPHAGUS BOUGIE APPLICATOR

K063815 is the FDA 510(k) clearance for VARIAN ESOPHAGUS BOUGIE APPLICATOR by Varian Medical Systems. It is a Class 2 Radiology device (product code JAQ) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K063815 · Varian Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
69d
Days
Class 2
Risk

K063815 is an FDA 510(k) clearance for the VARIAN ESOPHAGUS BOUGIE APPLICATOR. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Varian Medical Systems (Palo Alto, US). The FDA issued a Cleared decision on March 1, 2007 after a review of 69 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 devices

Submission Details

510(k) Number K063815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2006
Decision Date March 01, 2007
Days to Decision 69 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
38d faster than avg
Panel avg: 107d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 107
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K063815.
GAMMAMEDPLUS IX SERIES HDR AFTERLOADER
K071381 · Varian Medical Systems · Jul 2007
VARISOURCE IX HDR AFTERLOADER
K071467 · Varian Medical Systems, Inc. · Jul 2007
SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY
K071229 · Senorx, Inc. · May 2007
HDR CT COMPATIBLE SPLIT RING APPLICATOR
K063382 · Mick Radio-Nuclear Instruments, Inc. · Dec 2006
CT COMPATIBLE F/S/D APPLICATORS
K063381 · Mick Radio-Nuclear Instruments, Inc. · Dec 2006
VARISOURCE 200 HDR AFTERLOADER
K061582 · Varian Medical Systems, Inc. · Jul 2006