KARL STORZ ICG Imaging System— 510(k) K202925
Substantially EquivalentKarl Storz Endoscopy_America, Inc.
FDA 510(k) clearance K202925 for KARL STORZ ICG Imaging System, Substantially Equivalent on 2020-12-17. Applicant: Karl Storz Endoscopy_America, Inc.. Device class: 2.
Clearance details
- Applicant
- Karl Storz Endoscopy_America, Inc.
- Product code
- Code OWN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- El Segundo, CA, US
Recent devices under product code OWN
view allMore clearances from Karl Storz Endoscopy_America, Inc.
view allAdverse 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.