KARL STORZ Bipolar Resectoscopes with HF Cable— 510(k) K221893
Substantially EquivalentKarl Storz Endoscopy America, Inc.
FDA 510(k) clearance K221893 for KARL STORZ Bipolar Resectoscopes with HF Cable, Substantially Equivalent on 2023-03-17. Applicant: Karl Storz Endoscopy America, Inc.. Device class: 2.
Clearance details
- Applicant
- Karl Storz Endoscopy America, Inc.
- Product code
- Code FJL
- 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
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More clearances from Karl Storz Endoscopy America, Inc.
view allAdverse 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.