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510(k) K140803

LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM by Nucletron B.V. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2014
Date Received
March 31, 2014
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

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  • K132874 — LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SE (February 21, 2014)
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Other clearances for product code JAQ

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  • 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)