K250815
- 510(k) number
- K250815
- Device name
- Hubly Drill (H100)
- Applicant
- Hubly, Inc. IL · US
- Product code
- HBE — Drills, Burrs, Trephines & Accessories (Simple, Powe
- Decision date
- 2025-11-06
- Date received
- 2025-03-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K250815.pdf
Official FDA record: K250815
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.