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510(k) K161688

Advanced Gynecological Applicator by Nucletron B.V. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2017
Date Received
June 20, 2016
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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Other clearances for product code JAQ

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  • K243939 — Titanium Flexible Geometry FSD Applicator Set (GM11013400) (March 3, 2025)
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  • K242961 — Intraluminal Applicator Set (November 26, 2024)
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  • K241853 — Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve (November 7, 2024)
  • K241965 — Catheter Surface Flap Applicator Set (GM11011830) (October 29, 2024)