KARL STORZ ICG Imaging System— 510(k) K171238
Substantially EquivalentKARL STORZ Endoscopy-America, Inc.
FDA 510(k) clearance K171238 for KARL STORZ ICG Imaging System, Substantially Equivalent on 2017-05-25. Applicant: KARL STORZ Endoscopy-America, Inc..
Clearance details
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Product code
- Code OWN
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- El Segundo, CA, US
Adverse events under product code OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
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.