Cleared Traditional

VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER

K980601 · Varian Assoc., Inc. · Radiology

Oct 1998

Decision

246d

Days

Class 2

Risk

About This 510(k) Submission

K980601 is an FDA 510(k) clearance for the VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER, a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on October 21, 1998, 246 days after receiving the submission on February 17, 1998. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number	K980601 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 17, 1998
Decision Date	October 21, 1998
Days to Decision	246 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF