Cleared Traditional

K990753 - GRAC HIGH DOSE RATE (HDR) REMOTE AFTERL...

K990753 is the FDA 510(k) clearance for GRAC HIGH DOSE RATE (HDR) REMOTE AFTERL... by Cook, Inc.. It is a Class 2 Radiology device (product code JAQ) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K990753 · Cook, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
80d
Days
Class 2
Risk

K990753 is an FDA 510(k) clearance for the GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on May 27, 1999 after a review of 80 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K990753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1999
Decision Date May 27, 1999
Days to Decision 80 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
27d faster than avg
Panel avg: 107d · This submission: 80d
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 101
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K990753.
VAGINAL APPLICATOR SHIELDED
K001544 · Mick Radio-Nuclear Instruments, Inc. · Nov 2000
SEGMENTED VAGINAL APPLICATOR
K993472 · Mick Radio-Nuclear Instruments, Inc. · Jan 2000
HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES
K993400 · Mick Radio-Nuclear Instruments, Inc. · Jan 2000
VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
K981886 · Cook, Inc. · Nov 1998
VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
K980576 · Varian Medical Systems, Inc. · Nov 1998
VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
K980590 · Varian Medical Systems, Inc. · Oct 1998