EndoTool IV Cloud 1.0
FDA 510(k)Class II (US FDA 510(k))
by Glooko, Inc.
Identifiers
- 510(k) Number
- K260910 FDA 510(k)
- FDA Product Code
- NDC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1890 FDA 510(k)
- Regulation Number
- 868.1890 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EndoTool IV Cloud 1.0 is a Calculator, Drug Dose (FDA regulation 868.1890), designed to assist in the precise calculation and administration of intravenous drug dosages. This digital tool supports anesthesiology workflows by automating calculations to enhance patient safety and reduce human error during critical procedures.
Supplied as a cloud-based software solution, the EndoTool IV Cloud 1.0 is intended for single-use per session and does not require physical sterilization. It operates within Class 2 regulatory standards and has received FDA 510(k) clearance under the Traditional pathway (K260910). No MRI safety or physical size specifications are noted in the regulatory submission.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EndoTool IV Cloud 1.0 (K260910) — FDA 510 (k) | Innolitics, K260910 FDA 510 (k) - EndoTool IV Cloud 1.0 | Glooko, Inc., EndoTool IV Cloud 1.0 510 (k) K260910 - FDA.report, EndoTool IV Cloud 1.0 — FDA 510 (k) K260910 | MedTracker
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K260910 | Class II | Active |
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Manufacturer
- Manufacturer
- Glooko, Inc.
Sources (1)
- FDA 510(k) K260910 24 fields · synced Sep 19, 2026