FGA
10 FDA 510(k) clearances · Product code
173 daysmedian time to decision
267 days90th percentile
10clearances measured
FDA profile
- Official device name
- Kit, Nephroscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1998: 1 · 2000: 1 · 2024: 23 · 2025: 37
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Percutaneous Nephroscope System (K232370) | Karl Storz SE & CO. KG | 2024-05-01 |
| Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set (K151308) | Schoelly Fiberoptic GmbH | 2016-02-09 |
| GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM (K072594) | Gyrus Acmi, Inc. | 2007-12-13 |
| NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 (K994223) | Richard Wolf Medical Instruments Corp. | 2000-06-05 |
| KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES (K950433) | KARL STORZ Endoscopy-America, Inc. | 1995-03-15 |
| KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE (K940594) | KARL STORZ Endoscopy-America, Inc. | 1994-09-09 |
| FLEXIBLE FIBER OPTIC ENDOSCOPE (K922826) | Optimed Technologies, Inc. | 1993-02-19 |
| OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE (K853486) | Olympus Corp. | 1985-09-12 |
| ACMI RIGI-FLEX NEPHORSCOPE (K791182) | American Cystocope Makers, Inc. | 1979-07-30 |
| PYELOSCOPE SYSTEM (K770729) | Richard Wolf Medical Instruments Corp. | 1977-04-28 |
Track FGA automatically
Every clearance here is in the API, with alerts when new ones post.