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510(k) K253769

Instylla Delivery Kit by Instylla, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2025
Date Received
November 25, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Instylla, Inc.

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  • 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)

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