Hubly Drill (H100)— 510(k) K250815

Name: FDA 510(k) clearance K250815
Creator: U.S. Food and Drug Administration
Published: 2025-11-06

Substantially Equivalent

Hubly, Inc.

FDA 510(k) clearance K250815 for Hubly Drill (H100), Substantially Equivalent on 2025-11-06. Applicant: Hubly, Inc.. Device class: 2.

Clearance details

Applicant: Hubly, Inc.
Product code: Code HBE
Device class: Class 2
Regulation: 21 CFR 882.4310
Advisory panel: Neurology
Date received: 2025-03-17
Decision date: 2025-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lisle, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HBE

product code HBE

Injury: 306
Malfunction: 7,175
Other: 1
Total: 7,482

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.