MAKO Device— 510(k) K151275

Substantially Equivalent

Nvision Medical

FDA 510(k) clearance K151275 for MAKO Device, Substantially Equivalent on 2015-11-13. Applicant: Nvision Medical.

Clearance details

Applicant: Nvision Medical
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2015-05-13
Decision date: 2015-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.