Home / 510(k) Clearances / K010026

510(k) K010026

EMBOGOLD MICROSPHERE by Biosphere Medical, Inc. — Product Code HCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2001
Date Received
January 3, 2001
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 Biosphere Medical, Inc.

  • K250971 — Embosphere Microspheres (May 16, 2025)
  • K192480 — Torpedo Gelatin Foam (November 21, 2019)
  • K183120 — EmboCube Embolization Gelatin (August 6, 2019)
  • K183578 — Torpedo Gelatin Foam (June 18, 2019)
  • K181021 — EmboCube Embolization Gelatin (September 27, 2018)
  • K181300 — Embosphere Microspheres (July 16, 2018)
  • K172372 — QuadraSphere Microspheres (September 6, 2017)
  • DEN160040 — Embosphere Microspheres (June 21, 2017)
  • K153102 — QuadraSphere Microspheres (November 23, 2015)
  • K151187 — QuadraSphere Microspheres (July 27, 2015)

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)
  • 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)