Home / 510(k) Clearances / K052351

510(k) K052351

HDR IORT SHIELDED APPLICATOR by Mick Radio-Nuclear Instruments, Inc. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2005
Date Received
August 29, 2005
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 Mick Radio-Nuclear Instruments, Inc.

  • K230155 — Mick Valencia Applicator Set (August 30, 2023)
  • K200221 — CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Appl (February 28, 2020)
  • K150979 — CT/MR Compatible M.A.C. Interstitial GYN Template (May 31, 2016)
  • K142597 — Vienna System (February 19, 2015)
  • K122840 — CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 (December 14, 2012)
  • K063382 — HDR CT COMPATIBLE SPLIT RING APPLICATOR (December 26, 2006)
  • K063381 — CT COMPATIBLE F/S/D APPLICATORS (December 22, 2006)
  • K051423 — MICK HDR INTERSTITIAL IMPLANT ACCESSORIES (July 1, 2005)
  • K040704 — MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLI (June 18, 2004)
  • K033828 — CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406 (February 2, 2004)

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)