Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151308 FDA 510(k)
- FDA Product Code
- FGA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Schoelly Nephroscope Set and Ultra-Mini Nephroscope Set are medical instruments used for percutaneous nephrolithotomy (PCNL) procedures to remove kidney stones in the renal pelvis. These nephroscopes capture and display images on a monitor, featuring a high-quality, contrast-enhancing image bundle design.
The device is supplied as a set and is intended for single-use. It is manufactured by Schoelly Fiberoptic GmbH and has received FDA 510(k) clearance with the product code FGA. The device is not MRI compatible and should be stored according to the manufacturer's instructions.
Frequently asked questions
What is the Schoelly Nephroscope Set used for?
The Schoelly Nephroscope Set is used for percutaneous nephrolithotomy (PCNL) procedures to remove kidney stones in the renal pelvis. It captures and displays images on a monitor with a high-quality, contrast-enhancing image bundle design.
Is the Schoelly Nephroscope Set reusable or single-use?
The Schoelly Nephroscope Set is intended for single-use only. It should not be reused on multiple patients as this could compromise sterility and device performance.
What are the storage requirements for the Schoelly Nephroscope Set?
The device should be stored according to the manufacturer's instructions. It is not MRI compatible, so proper storage conditions must ensure the device remains functional until use.
What regulatory approvals does the Schoelly Nephroscope Set have?
The Schoelly Nephroscope Set has received FDA 510(k) clearance with product code FGA. It is classified as a Class 2 device and is intended for use in gastroenterology and urology procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Nephroscopes - SCHÖLLY Fiberoptic GmbH - SCHOELLY, Schoelly Nephroscope Set Schoelly Ultra-Mini Nephroscope Set, Medical Endoscopy Downloads - SCHÖLLY Fiberoptic GmbH - SCHOELLY, Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set by ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151308 | Class II | Active |
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Manufacturer
- Manufacturer
- Schoelly Fiberoptic GmbH
Sources (1)
- FDA 510(k) K151308 24 fields · synced Sep 27, 2026