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510(k) K242154

Numen™ Coil Embolization System; NumenFR™ Detachment System by MicroPort NeuroTech (Shanghai) Co., Ltd. — Product Code HCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2024
Date Received
July 23, 2024
Clearance Type
Special
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 MicroPort NeuroTech (Shanghai) Co., Ltd.

  • K232955 — Numen Coil Embolization System; NumenFR Detachment System (January 10, 2024)
  • K203625 — Numen Coil Embolization System; NumenFR Detachment System (September 1, 2021)

Other clearances for product code HCG

  • K254221 — Optima Coil System (OptiOne Coil System) (January 27, 2026)
  • K252694 — Target Detachable Coil (December 11, 2025)
  • K251832 — InZone IST Detachment System; IZDS Connecting Cable (October 17, 2025)
  • K252700 — Optima Coil System (Optima Packing Coil System) (September 26, 2025)
  • 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)
  • K222533 — Target Tetra Detachable Coils (December 14, 2022)