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510(k) K240495

Flexible Fixation Device for Gynecological Applicators (GM11001960) by Varian Medical Systems, Inc. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2024
Date Received
February 20, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type

Other clearances by Varian Medical Systems, Inc.

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  • K250099 — Mobius3D (4.1) (May 16, 2025)
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  • K243939 — Titanium Flexible Geometry FSD Applicator Set (GM11013400) (March 3, 2025)
  • K242957 — Identify (4.0) (February 7, 2025)
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Other clearances for product code JAQ

  • K251037 — Rectal Applicator (December 19, 2025)
  • K252884 — Guided Aarhus Applicator Set (November 19, 2025)
  • K250299 — CT/ MR Tandem and Ovoid Set (May 9, 2025)
  • K250289 — Intracavitary/Interstitial System (April 25, 2025)
  • K243939 — Titanium Flexible Geometry FSD Applicator Set (GM11013400) (March 3, 2025)
  • K241764 — Mould Probe MR Safe (January 10, 2025)
  • K242961 — Intraluminal Applicator Set (November 26, 2024)
  • K243045 — “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) (November 19, 2024)
  • K241853 — Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve (November 7, 2024)
  • K241965 — Catheter Surface Flap Applicator Set (GM11011830) (October 29, 2024)