Cleared Traditional

Flexible Fixation Device for Gynecological Applicators (GM11001960)

K240495 · Varian Medical Systems, Inc. · Radiology
May 2024
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K240495 is an FDA 510(k) clearance for the Flexible Fixation Device for Gynecological Applicators (GM11001960), 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 May 9, 2024, 79 days after receiving the submission on February 20, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K240495 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2024
Decision Date May 09, 2024
Days to Decision 79 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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