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510(k) K253677

Tembo Embolic System by Instylla, Inc. — Product Code KRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2025
Date Received
November 21, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Vascular, For Promoting Embolization
Device Class
Class II
Regulation Number
870.3300
Review Panel
CV
Submission Type

Other clearances by Instylla, Inc.

  • K253769 — Instylla Delivery Kit (December 22, 2025)
  • K240873 — TEMBO Embolic System (December 16, 2024)
  • K213632 — Instylla Delivery Kit (February 10, 2022)
  • K210808 — Instylla Microcatheter 1.2 (April 15, 2021)
  • K202544 — Instylla Delivery Kit (January 7, 2021)
  • K200744 — Instylla Microcatheter (April 21, 2020)
  • K191659 — Instylla Delivery Kit (October 10, 2019)
  • K191731 — Instylla Microcatheter (August 13, 2019)

Other clearances for product code KRD

  • K253511 — Concerto Versa™ Detachable Coil (January 14, 2026)
  • K253376 — OBSIDIO™ Conformable Embolic (M0013972101010) (October 30, 2025)
  • K250209 — Polyvinyl Alcohol Embolic Microspheres (September 23, 2025)
  • K250133 — HARBOR Occlusion Device (July 9, 2025)
  • K251383 — Prestige Coil System (Prestige Packing Line Extension) (May 30, 2025)
  • K250971 — Embosphere Microspheres (May 16, 2025)
  • K250276 — Nitinol Enhanced Device (NED) (May 15, 2025)
  • K250079 — Ruby XL System (March 14, 2025)
  • K242608 — Embozene Color-Advanced Microspheres (January 17, 2025)
  • K240873 — TEMBO Embolic System (December 16, 2024)