Product code FGA
- Device name
- Kit, Nephroscope
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232370 | Percutaneous Nephroscope System | Karl Storz SE & CO. KG | 2024-05-01 |
| K151308 | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set | Schoelly Fiberoptic GmbH | 2016-02-09 |
| K072594 | GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM | Gyrus Acmi, Inc. | 2007-12-13 |
| K994223 | NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 | Richard Wolf Medical Instruments Corp. | 2000-06-05 |
| K950433 | KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES | KARL STORZ Endoscopy-America, Inc. | 1995-03-15 |
| K940594 | KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE | KARL STORZ Endoscopy-America, Inc. | 1994-09-09 |
| K922826 | FLEXIBLE FIBER OPTIC ENDOSCOPE | Optimed Technologies, Inc. | 1993-02-19 |
| K853486 | OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE | Olympus Corp. | 1985-09-12 |
| K791182 | ACMI RIGI-FLEX NEPHORSCOPE | American Cystocope Makers, Inc. | 1979-07-30 |
| K770729 | PYELOSCOPE SYSTEM | Richard Wolf Medical Instruments Corp. | 1977-04-28 |
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| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10810068811114 | MONARCH™ Mini-PCNL Suction Set | Auris Health, Inc. | 2026-05-05 |
| 00810143891294 | Strauss Surgical | AMERICAN MEDICAL ENDOSCOPY, INC. | 2025-04-25 |
| 00814334022856 | COBRA VISION | Richard Wolf GmbH | 2021-07-15 |
| 00814334022832 | BOA VISION | Richard Wolf GmbH | 2021-07-15 |
| 10888439694475 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2020-01-24 |
| 10888439603354 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-10-31 |
| 10888439511611 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-06-21 |
| 10888439279085 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-02-20 |
| 10888439008227 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2018-06-28 |
| 10887488885698 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2018-01-29 |
| 10887488809021 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2017-12-29 |
| 10887488841113 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2017-11-29 |
| 10887488825106 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2017-11-28 |
| 10887488849515 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2017-10-24 |
| 10887488786902 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2017-09-22 |
| 10887488784441 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2017-09-08 |
| 10887488697451 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2017-06-02 |
| 10887488608464 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2017-01-06 |
| 10887488609027 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-10-26 |
| 10887488619200 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-10-24 |
| 10887488595832 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-10-12 |
| 10887488578590 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-10-11 |
| 04042761051842 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-21 |
| 04042761051835 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-21 |
| 04042761051828 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-21 |
| 04042761023207 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-21 |
| 04042761005210 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-21 |
| 14042761001707 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-21 |
| 00885425879970 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2015-10-12 |
| 10887488128061 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2015-07-23 |