Aurora Surgiscope System— 510(k) K191861
Substantially EquivalentRebound Therapeutics
FDA 510(k) clearance K191861 for Aurora Surgiscope System, Substantially Equivalent on 2019-12-06. Applicant: Rebound Therapeutics. Device class: 2.
Clearance details
- Applicant
- Rebound Therapeutics
- Product code
- Code GWG
- Device class
- Class 2
- Regulation
- 21 CFR 882.1480
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code GWG
view allMore clearances from Rebound Therapeutics
view allAdverse events under product code GWG
product code GWG- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . 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.