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. Device class: 2.
Clearance details
- Applicant
- Schoelly Fiberoptic GmbH
- Product code
- Code FGA
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Denzlingen, DE
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More clearances from Schoelly Fiberoptic GmbH
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- K201617 — TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
- K201970 — Schoelly Cystoscopes/Hysteroscopes and Accessories
- K150158 — Schoelly Cystoscopes/Hysteroscopes and Accessories
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.