Aurora Surgiscope System— 510(k) K191861

Substantially Equivalent

Rebound Therapeutics

FDA 510(k) clearance K191861 for Aurora Surgiscope System, Substantially Equivalent on 2019-12-06. Applicant: Rebound Therapeutics.

Clearance details

Applicant: Rebound Therapeutics
Product code: Code GWG
Advisory panel: Neurology
Date received: 2019-07-11
Decision date: 2019-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

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.