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510(k) K233628

AOS Interstitial Templates, Needles, and Accessories by Alpha-Omega Services, Inc. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2024
Date Received
November 13, 2023
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 Alpha-Omega Services, Inc.

  • K233626 — AOS Marker Seeds (SMG0242-025) (July 2, 2024)
  • K102811 — AOS ORION IR-192 SOURCE CABLE (June 2, 2011)
  • K062824 — AOS UNIVERSAL CONECTING GUIDE TUBE (July 3, 2007)
  • K062823 — AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES (May 29, 2007)
  • K062825 — AOS MARKER SEEDS (May 22, 2007)
  • K062826 — AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS (May 22, 2007)
  • K991571 — 10 CURIE IRDIUM 192, CSN00100-192 (February 22, 2000)
  • K964910 — AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS (March 10, 1997)

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)