FGA — Kit, Nephroscope Class II
FDA product code FGA covers "Kit, Nephroscope", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FGA
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232370 | karl storz se and co. kg | Percutaneous Nephroscope System | May 1, 2024 |
| K151308 | schoelly fiberoptic | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set | February 9, 2016 |
| K072594 | gyrus acmi | GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM | December 13, 2007 |
| K994223 | richard wolf medical instruments | NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 | June 5, 2000 |
| K950433 | karl storz endoscopy-america | KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES | March 15, 1995 |
| K940594 | karl storz endoscopy-america | KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE | September 9, 1994 |
| K922826 | optimed technologies | FLEXIBLE FIBER OPTIC ENDOSCOPE | February 19, 1993 |
| K853486 | olympus | OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE | September 12, 1985 |
| K791182 | american cystocope makers | ACMI RIGI-FLEX NEPHORSCOPE | July 30, 1979 |
| K770729 | richard wolf medical instruments | PYELOSCOPE SYSTEM | April 28, 1977 |