Cleared Traditional

Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve

K241853 · Varian Medical Systems, Inc. · Radiology
Nov 2024
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K241853 is an FDA 510(k) clearance for the Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve, 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 November 7, 2024, 133 days after receiving the submission on June 27, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K241853 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2024
Decision Date November 07, 2024
Days to Decision 133 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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