Home / 510(k) Clearances / K062823

510(k) K062823

AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES by Alpha-Omega Services, Inc. — Product Code JAQ

K062823 is an FDA 510(k) premarket notification submitted by Alpha-Omega Services, Inc. for the device "AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES". The FDA issued a decision of Substantially Equivalent on May 29, 2007. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Alpha-Omega Services, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2007
Date Received
September 20, 2006
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.

  • K233628 — AOS Interstitial Templates, Needles, and Accessories (July 10, 2024)
  • 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)
  • K062826 — AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS (May 22, 2007)
  • K062825 — AOS MARKER SEEDS (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

  • K252717 — MAASTRO Rectal Applicator Set (May 20, 2026)
  • 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)

FDA data resources