Cleared Traditional

Titanium Flexible Geometry FSD Applicator Set (GM11013400)

K243939 · Varian Medical Systems, Inc. · Radiology
Mar 2025
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K243939 is an FDA 510(k) clearance for the Titanium Flexible Geometry FSD Applicator Set (GM11013400), a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on March 3, 2025, 73 days after receiving the submission on December 20, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K243939 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2024
Decision Date March 03, 2025
Days to Decision 73 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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