Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set— 510(k) K151308
Substantially EquivalentSchoelly Fiberoptic GmbH
FDA 510(k) clearance K151308 for Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set, Substantially Equivalent on 2016-02-09. Applicant: Schoelly Fiberoptic GmbH.
Clearance details
- Applicant
- Schoelly Fiberoptic GmbH
- Product code
- Code FGA
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Denzlingen, DE
Adverse events under product code FGA
product code FGA- Death
- 7
- Total
- 7
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.