Aurora Surgiscope System— 510(k) K232618
Substantially EquivalentRebound Therapeutics Corporation
FDA 510(k) clearance K232618 for Aurora Surgiscope System, Substantially Equivalent on 2023-10-27. Applicant: Rebound Therapeutics Corporation. Device class: 2.
Clearance details
- Applicant
- Rebound Therapeutics Corporation
- 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 Corporation
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 K232618
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 K232618.
Data sourced from openFDA. This site is unofficial and independent of the FDA.