Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
FDA 510(k) K151308 · Schoelly Fiberoptic GmbH
510(k) numberK151308
Submission
- Device name
- Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
- Applicant
- Schoelly Fiberoptic GmbH
Denzlingen, DE - Received
- May 18, 2015
- Decision date
- February 9, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FGA – Kit, Nephroscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FGA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232370 | Percutaneous Nephroscope SystemFGA · Traditional | Karl Storz SE & CO. KG | 05/01/2024SE |
| K072594 | Gyrus Acmi IPN-2505, Invisio Smith Percutaneous Nephroscope SystemFGA · Traditional | Gyrus Acmi, Inc. | 12/13/2007SE |
| K994223 | Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope, 20 Degree…FGA · Traditional | Richard Wolf Medical Instruments Corp. | 06/05/2000SE |
| K950433 | Karl Storz Endopyelotomy Set for Endoscopic Urology ProceduresFGA · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/15/1995SE |
| K940594 | Karl Storz Adult & Pediatric NephroscopeFGA · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/09/1994SE |
| K922826 | Flexible Fiber Optic EndoscopeFGA · Traditional | Optimed Technologies, Inc. | 02/19/1993SE |
| K853486 | Olympus Rigid Percutaneous NephroscopeFGA · Traditional | Olympus Corp. | 09/12/1985SE |
| K791182 | Acmi Rigi-Flex NephorscopeFGA · Traditional | American Cystocope Makers, Inc. | 07/30/1979SE |
| K770729 | Pyeloscope SystemFGA · Traditional | Richard Wolf Medical Instruments Corp. | 04/28/1977SE |
More from Richard Wolf Medical Instruments Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K233225 | SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…GCJ · Traditional | 06/20/2024SE |
| K221591 | Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)…GCJ · Traditional | 02/23/2023SE |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…HET · Traditional | 03/12/2021SE |
| K201970 | Schoelly Cystoscopes/Hysteroscopes and AccessoriesHIH · Traditional | 10/08/2020SE |
| K150158 | Schoelly Cystoscopes/Hysteroscopes and AccessoriesHIH · Traditional | 03/09/2015SE |
| K143673 | CMOS Video Nasopharyngoscope SystemEOB · Special | 03/04/2015SE |
| K142249 | Schoelly SinuscopeEOB · Traditional | 01/27/2015SE |
| K143221 | Schoelly LaparoscopeGCJ · Special | 12/05/2014SE |
| K132009 | Cmos Video Nasopharyngoscope SystemEOB · Traditional | 04/09/2014SE |
| K992362 | Flexiscope Iq 101FET · Traditional | 08/05/1999SE |
Questions and answers
When was Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set cleared by the FDA?
Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set (K151308) received a 510(k) decision of Substantially Equivalent on February 9, 2016, 267 days after the submission was received.
What is the product code of K151308?
The FDA product code is FGA – Kit, Nephroscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.