KARL STORZ DIRECT COUPLED CAMERA HEAD— 510(k) K973252
Substantially EquivalentKarl Storz Imaging, Inc.
FDA 510(k) clearance K973252 for KARL STORZ DIRECT COUPLED CAMERA HEAD, Substantially Equivalent on 1997-11-24. 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.