KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM— 510(k) K003325
Substantially EquivalentKarl Storz Imaging, Inc.
FDA 510(k) clearance K003325 for KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM, Substantially Equivalent on 2001-04-27. Applicant: Karl Storz Imaging, Inc.. Device class: 2.
Clearance details
- Applicant
- Karl Storz Imaging, Inc.
- Product code
- Code FET
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goleta, CA, US
Recent devices under product code FET
view allMore clearances from Karl Storz Imaging, Inc.
view allAdverse events under product code FET
product code FET- Injury
- 313
- Malfunction
- 54,276
- Total
- 54,589
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.