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510(k) K260910

EndoTool IV Cloud 1.0 by Glooko, Inc. — Product Code NDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2026
Date Received
March 19, 2026
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 Glooko, Inc.

  • K171450 — Glooko Mobile Insulin Dosing System (February 2, 2018)
  • K132272 — GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION (October 17, 2013)
  • K130886 — GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION (April 25, 2013)
  • K122142 — GLOOKO LOGBOOK CHARTS (December 21, 2012)

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