K252662
- 510(k) number
- K252662
- Device name
- UniBur
- Applicant
- Nakanishi, Inc. JP
- Product code
- HBE — Drills, Burrs, Trephines & Accessories (Simple, Powe
- Decision date
- 2025-09-19
- Date received
- 2025-08-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252662.pdf
Official FDA record: K252662
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.