Cleared Traditional

Advanced Gynecological Applicator

K161688 · Nucletron B.V. · Radiology
Jan 2017
Decision
221d
Days
Class 2
Risk

About This 510(k) Submission

K161688 is an FDA 510(k) clearance for the Advanced Gynecological Applicator, a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Nucletron B.V. (Veenendaal, NL). The FDA issued a Cleared decision on January 27, 2017, 221 days after receiving the submission on June 20, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K161688 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2016
Decision Date January 27, 2017
Days to Decision 221 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAQ — System, Applicator, Radionuclide, Remote-controlled
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5700

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