# FBO: Cystourethroscope

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 19
- 510(k) review time 2021–2025: median 77 days (middle half 51–102)
- Recalls: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1995: 3
- 1996: 1
- 1997: 1
- 2001: 1
- 2006: 1
- 2007: 1
- 2008: 2
- 2014: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- K843084: Olympus CHP-P10 Nephroscope/Cystoscope (1985), cited by 3
- K945185: Cystoscope (78FAJ)Endoscope,Fiberoptic (78GDB) (1995), cited by 2
- K904797: Surgitek Graduated Cystoscope (Model GC-16) (1991), cited by 2
- K131364: Flexible Cmos-Video-Cysto-Urethroscope (2014), cited by 2
- K011496: Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and Forceps Model 8650, 8652, 8660 (2001), cited by 2
- K962474: Olympus FG Series of Rat Tooth Grasping Forceps (Urology) (1996), cited by 2
- K951972: Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic Sheaths (1995), cited by 2
- K062918: Karl Storz Flexible Video-Urethro-Cystoscope System (2007), cited by 1
- K082046: Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope, Model 11278C1/Acui and Circon Aur-735 Pediatric Cystouretherosco (2008), cited by 1

Source page: https://510kreport.com/product-code/FBO
Data by year (CSV): https://510kreport.com/product-code/FBO.csv