Cleared Traditional

K241965 - Catheter Surface Flap Applicator Set (GM11011830)
(FDA 510(k) Clearance)

K241965 · Varian Medical Systems · Radiology

Oct 2024

Decision

118d

Days

Class 2

Risk

K241965 is an FDA 510(k) clearance for the Catheter Surface Flap Applicator Set (GM11011830), a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Varian Medical Systems (Palo Alto, US). The FDA issued a Cleared decision on October 29, 2024, 118 days after receiving the submission on July 3, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number	K241965 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2024
Decision Date	October 29, 2024
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF