SYMBIS Surgical System— 510(k) K143420

Substantially Equivalent

Imris, Inc.

FDA 510(k) clearance K143420 for SYMBIS Surgical System, Substantially Equivalent on 2015-10-30. Applicant: Imris, Inc..

Clearance details

Applicant: Imris, Inc.
Product code: Code HAW
Advisory panel: Neurology
Date received: 2014-11-28
Decision date: 2015-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.