KARL STORZ Flexible HD Cysto-Urethroscope System— 510(k) K212476
Substantially EquivalentKarl Storz Endoscopy America, Inc.
FDA 510(k) clearance K212476 for KARL STORZ Flexible HD Cysto-Urethroscope System, Substantially Equivalent on 2021-09-03. Applicant: Karl Storz Endoscopy America, Inc..
Clearance details
- Applicant
- Karl Storz Endoscopy America, Inc.
- Product code
- Code FAJ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- El Segundo, CA, US
Adverse events under product code FAJ
product code FAJ- Injury
- 533
- Malfunction
- 6,705
- Total
- 7,238
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.