Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)— 510(k) K201840
Substantially EquivalentRebound Therapeutics
FDA 510(k) clearance K201840 for Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box), Substantially Equivalent on 2020-11-04. 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 →
Recalls naming K201840
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201840.
Data sourced from openFDA. This site is unofficial and independent of the FDA.