FBO — Cystourethroscope Class II
FDA product code FBO covers "Cystourethroscope", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 19 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FBO
- 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 |
|---|---|---|---|
| K244001 | karl storz se and co. kg | KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fibersc | May 2, 2025 |
| K243409 | karl storz se and co. kg | KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) | November 27, 2024 |
| K131364 | karl storz endoscopy-america | FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE | January 2, 2014 |
| K082046 | karl storz endoscopy-america | KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND C | October 10, 2008 |
| K080780 | epitek | ANCHORAGE SCOPE, MODEL 000003 | July 30, 2008 |
| K062918 | karl storz endoscopy-america | KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM | January 17, 2007 |
| K061646 | laserscope | LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES | June 27, 2006 |
| K011496 | richard wolf medical instruments | CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENT | August 10, 2001 |
| K972979 | smith and nephew | SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RI | December 11, 1997 |
| K962474 | olympus america | OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) | December 20, 1996 |
| K941992 | surgical technologies | CYSTOSCOPE | November 30, 1995 |
| K951972 | cabot medical | CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SH | July 21, 1995 |
| K945185 | karl storz endoscopy-america | CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB) | May 3, 1995 |
| K934649 | galileo electro-optics | GALILEO ENDOSCOPES | October 13, 1994 |
| K943668 | karl storz endoscopy-america | KSEA CONTINOUS FLOW CYSTOSCOPE | September 21, 1994 |
| K935163 | richard wolf medical instruments | CONTINUOUS IRRIGATION CYSTOURETHROSCOPE | September 7, 1994 |
| K904797 | surgitek | SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16) | March 5, 1991 |
| K870679 | van-tec | VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE | March 30, 1987 |
| K843084 | olympus | OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE | January 3, 1985 |