Kit, Nephroscope
The Nephroscope Kit is a set of components used in nephroscopy, the endoscopic examination of the renal pelvis and kidney, typically to diagnose and treat conditions such as kidney stones or upper urinary tract lesions. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FGA, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology medical specialty.
Basic Information
- Product Code
- FGA
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K232370 | Percutaneous Nephroscope System | May 01, 2024 | Substantially Equivalent | Karl Storz SE & CO. KG |
| K151308 | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set | Feb 09, 2016 | Substantially Equivalent | Schoelly Fiberoptic GmbH |
| K072594 | GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM | Dec 13, 2007 | Substantially Equivalent | Gyrus Acmi, Inc. |
| K994223 | NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 | Jun 05, 2000 | Substantially Equivalent | Richard Wolf Medical Instruments Corp. |
| K950433 | KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES | Mar 15, 1995 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K940594 | KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE | Sep 09, 1994 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K922826 | FLEXIBLE FIBER OPTIC ENDOSCOPE | Feb 19, 1993 | Substantially Equivalent | Optimed Technologies, Inc. |
| K853486 | OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE | Sep 12, 1985 | Substantially Equivalent | Olympus Corp. |
| K791182 | ACMI RIGI-FLEX NEPHORSCOPE | Jul 30, 1979 | Substantially Equivalent | American Cystocope Makers, Inc. |
| K770729 | PYELOSCOPE SYSTEM | Apr 28, 1977 | Substantially Equivalent | Richard Wolf Medical Instruments Corp. |
FEI Numbers
This FDA classification entry is associated with 34 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.