FDA.reportPublic FDA data

510(k) K243939

Device
Titanium Flexible Geometry FSD Applicator Set (GM11013400)
Applicant
Varian Medical Systems, Inc.
510(k) number
K243939
Product code
JAQ
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-03
Date received
2024-12-20
Regulation
892.5700
Classification name
System, Applicator, Radionuclide, Remote-Controlled
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Lynn Allman
Address
3100 Hansen Way Palo Alto CA US 94304 94304

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JAQ#

510(k), Device, Applicant table
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K241853Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical SleeveVarian Medical Systems, Inc.2024-11-07
K241965Catheter Surface Flap Applicator Set (GM11011830)Varian Medical Systems2024-10-29
K241386Heyman Packing Applicator Set (GM11004580)Varian Medical Systems, Inc.2024-08-30
K233628AOS Interstitial Templates, Needles, and AccessoriesAlpha-Omega Services, Inc.2024-07-10
K233626AOS Marker Seeds (SMG0242-025)Alpha-Omega Services, Inc.2024-07-02
K240495Flexible Fixation Device for Gynecological Applicators (GM11001960)Varian Medical Systems, Inc.2024-05-09