Cleared Traditional

Heyman Packing Applicator Set (GM11004580)

K241386 · Varian Medical Systems, Inc. · Radiology
Aug 2024
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K241386 is an FDA 510(k) clearance for the Heyman Packing Applicator Set (GM11004580), 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 August 30, 2024, 107 days after receiving the submission on May 15, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K241386 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2024
Decision Date August 30, 2024
Days to Decision 107 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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