KARL STORZ Monopolar Resectoscopes with HF Cable— 510(k) K232486
Substantially EquivalentKarl Storz SE & CO. KG
FDA 510(k) clearance K232486 for KARL STORZ Monopolar Resectoscopes with HF Cable, Substantially Equivalent on 2024-05-07. Applicant: Karl Storz SE & CO. KG.
Clearance details
- Applicant
- Karl Storz SE & CO. KG
- Product code
- Code FJL
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tuttlingen, DE
Adverse events under product code FJL
product code FJL- Death
- 2
- Total
- 2
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.