KARL STORZ ICG Imaging System— 510(k) K180146
Substantially EquivalentKarl Storz Endoscopy America, Inc.
FDA 510(k) clearance K180146 for KARL STORZ ICG Imaging System, Substantially Equivalent on 2018-04-17. Applicant: Karl Storz Endoscopy America, Inc.. Device class: 2.
Clearance details
- Applicant
- Karl Storz Endoscopy America, Inc.
- 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
- El Segundo, CA, US
Recent devices under product code GWG
view allMore clearances from Karl Storz Endoscopy America, Inc.
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.