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510(k) K251832

InZone IST Detachment System; IZDS Connecting Cable by Stryker Neurovascular — Product Code HCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2025
Date Received
June 16, 2025
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 Stryker Neurovascular

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  • K243593 — AXS Lift Intracranial Base Catheter (February 18, 2025)
  • K241637 — Echo Intracranial Base Catheter (December 19, 2024)
  • K241768 — Broadway 8 Catheter (December 19, 2024)
  • K223305 — Trevo NXT ProVue Retriever (March 29, 2023)
  • K222533 — Target Tetra Detachable Coils (December 14, 2022)
  • K211594 — Trevo Trak 21 Microcatheter (November 26, 2021)
  • K212455 — InZone Detachment System (November 16, 2021)

Other clearances for product code HCG

  • K254221 — Optima Coil System (OptiOne Coil System) (January 27, 2026)
  • K252694 — Target Detachable Coil (December 11, 2025)
  • 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)
  • K222533 — Target Tetra Detachable Coils (December 14, 2022)