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510(k) K192068

i-ED COIL by Kaneka Pharma America, LLC — Product Code HCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2020
Date Received
August 1, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Neurovascular Embolization
Device Class
Class II
Regulation Number
882.5950
Review Panel
NE
Submission Type

Other clearances by Kaneka Pharma America, LLC

  • K170247 — Lacriflow CL (April 18, 2017)
  • K121301 — XPRESSWAY RX CATHETER (6F LD-VERISON) (July 30, 2012)
  • K101839 — KANEKA PHARMA AMERICA XPRESS-WAY RX (October 22, 2010)

Other clearances for product code HCG

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  • K252700 — Optima Coil System (Optima Packing Coil System) (September 26, 2025)
  • K242154 — Numen™ Coil Embolization System; NumenFR™ Detachment System (September 30, 2024)
  • K242582 — Optima Coil System (OptiBlock Line Extension) (September 27, 2024)
  • K242243 — Target Detachable Coils (August 29, 2024)
  • K232955 — Numen Coil Embolization System; NumenFR Detachment System (January 10, 2024)
  • K233420 — Axium Detachable Coil; Axium Prime Detachable Coil (November 7, 2023)
  • K230284 — Penumbra LP Coil System (October 25, 2023)