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510(k) K241088

EndoTool IV (3.1) by Monarch Medical Technologies — Product Code NDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2024
Date Received
April 19, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Drug Dose
Device Class
Class II
Regulation Number
868.1890
Review Panel
CH
Submission Type

Other clearances by Monarch Medical Technologies

  • K211160 — EndoTool SubQ 2.1 (October 28, 2021)
  • K201619 — EndoTool IV System (August 7, 2020)
  • K200443 — EndoTool IV 1.10 (March 17, 2020)
  • K142918 — EndoTool SubQ (April 24, 2015)
  • K132547 — ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS) (April 17, 2014)

Other clearances for product code NDC

  • K253512 — MiniMed Go App (January 8, 2026)
  • K253281 — UpDoc (December 23, 2025)
  • K252104 — T1D1 (August 20, 2025)
  • K242775 — InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (November 12, 2024)
  • K242066 — iSage Rx (August 21, 2024)
  • K232451 — Insulia Bolus Companion (December 12, 2023)
  • K230813 — BlueStar and BlueStar Rx (July 28, 2023)
  • K221924 — Digital Routines (March 15, 2023)
  • K211160 — EndoTool SubQ 2.1 (October 28, 2021)
  • K203434 — BlueStar Rx (September 8, 2021)