EndoTool IV Cloud 1.0— 510(k) K260910

Substantially Equivalent

Glooko, Inc.

FDA 510(k) clearance K260910 for EndoTool IV Cloud 1.0, Substantially Equivalent on 2026-05-01. Applicant: Glooko, Inc..

Clearance details

Applicant: Glooko, Inc.
Product code: Code NDC
Advisory panel: Anesthesiology
Date received: 2026-03-19
Decision date: 2026-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NDC

product code NDC

Malfunction: 1,390
Total: 1,390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.