FDA Product Code
FDA Product Code FGA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232370 | Percutaneous Nephroscope System | Karl Storz SE & CO. KG | 2024-05-01 | Traditional | PDF ↗ |
| K151308 | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set | Schoelly Fiberoptic GmbH | 2016-02-09 | Traditional | PDF ↗ |
| K072594 | GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM | Gyrus Acmi, Inc. | 2007-12-13 | Traditional | PDF ↗ |
| K994223 | NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 | Richard Wolf Medical Instruments Corp. | 2000-06-05 | Traditional | PDF ↗ |
| K950433 | KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES | KARL STORZ Endoscopy-America, Inc. | 1995-03-15 | Traditional | PDF ↗ |
| K940594 | KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE | KARL STORZ Endoscopy-America, Inc. | 1994-09-09 | Traditional | PDF ↗ |
| K922826 | FLEXIBLE FIBER OPTIC ENDOSCOPE | Optimed Technologies, Inc. | 1993-02-19 | Traditional | PDF ↗ |
| K853486 | OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE | Olympus Corp. | 1985-09-12 | Traditional | PDF ↗ |
| K791182 | ACMI RIGI-FLEX NEPHORSCOPE | American Cystocope Makers, Inc. | 1979-07-30 | Traditional | PDF ↗ |
| K770729 | PYELOSCOPE SYSTEM | Richard Wolf Medical Instruments Corp. | 1977-04-28 | Traditional | PDF ↗ |
Product code FGA · Class II · Gastroenterology, Urology. Data: openFDA.