Product code FBO
- Device name
- Cystourethroscope
- 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 |
|---|---|---|---|
| K244001 | KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) | Karl Storz SE & CO. KG | 2025-05-02 |
| K243409 | KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) | Karl Storz SE & CO. KG | 2024-11-27 |
| K131364 | FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE | KARL STORZ Endoscopy-America, Inc. | 2014-01-02 |
| K082046 | KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO | KARL STORZ Endoscopy-America, Inc. | 2008-10-10 |
| K080780 | ANCHORAGE SCOPE, MODEL 000003 | Epitek, Inc. | 2008-07-30 |
| K062918 | KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM | KARL STORZ Endoscopy-America, Inc. | 2007-01-17 |
| K061646 | LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES | Laserscope | 2006-06-27 |
| K011496 | CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 | Richard Wolf Medical Instruments Corp. | 2001-08-10 |
| K972979 | SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM | Smith & Nephew, Inc. | 1997-12-11 |
| K962474 | OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) | Olympus America, Inc. | 1996-12-20 |
| K941992 | CYSTOSCOPE | Surgical Technologies, Inc. | 1995-11-30 |
| K951972 | CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS | Cabot Medical Corp. | 1995-07-21 |
| K945185 | CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB) | KARL STORZ Endoscopy-America, Inc. | 1995-05-03 |
| K934649 | GALILEO ENDOSCOPES | Galileo Electro-Optics Corp. | 1994-10-13 |
| K943668 | KSEA CONTINOUS FLOW CYSTOSCOPE | KARL STORZ Endoscopy-America, Inc. | 1994-09-21 |
| K935163 | CONTINUOUS IRRIGATION CYSTOURETHROSCOPE | Richard Wolf Medical Instruments Corp. | 1994-09-07 |
| K904797 | SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16) | Surgitek | 1991-03-05 |
| K870679 | VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE | Van-Tec, Inc. | 1987-03-30 |
| K843084 | OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE | Olympus Corp. | 1985-01-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04048438000175 | NA | Karl Storz GmbH & Co. KG | 2025-03-27 |
| 04048551431382 | n.a. | Karl Storz GmbH & Co. KG | 2024-11-28 |
| 04055207066218 | E-LINE | Richard Wolf GmbH | 2020-02-21 |
| 04055207066225 | E-LINE | Richard Wolf GmbH | 2020-02-21 |
| 04055207066195 | E-LINE | Richard Wolf GmbH | 2020-02-21 |
| 04055207066201 | E-LINE | Richard Wolf GmbH | 2020-02-21 |
| 04048551390184 | n.a. | Karl Storz GmbH & Co. KG | 2016-12-22 |
| 04048551390160 | n.a. | Karl Storz GmbH & Co. KG | 2016-12-22 |
| 04048551390139 | n.a. | Karl Storz GmbH & Co. KG | 2016-12-22 |
| 00821925038547 | Gyrus ACMI | Gyrus ACMI, LLC | 2016-10-18 |
| 04048551226186 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551007471 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551073926 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551366844 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551313367 | C-VIEW | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551313350 | C-VIEW | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551275757 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551275665 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551257104 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551226193 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551076545 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551226162 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551226100 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551078600 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551078563 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551078228 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551078167 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551078136 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551077412 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551076569 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |