UniBur— 510(k) K252662

Substantially Equivalent

Nakanishi, Inc.

FDA 510(k) clearance K252662 for UniBur, Substantially Equivalent on 2025-09-19. Applicant: Nakanishi, Inc..

Clearance details

Applicant: Nakanishi, Inc.
Product code: Code HBE
Advisory panel: Neurology
Date received: 2025-08-22
Decision date: 2025-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kanuma, JP

Download summary PDF View on FDA.gov ↗

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.