Cleared Traditional

Universal Endometrial Applicator Set (GM11009840)

K232623 · Varian Medical Systems, Inc. · Radiology
Apr 2024
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K232623 is an FDA 510(k) clearance for the Universal Endometrial Applicator Set (GM11009840), 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 April 9, 2024, 224 days after receiving the submission on August 29, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K232623 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2023
Decision Date April 09, 2024
Days to Decision 224 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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