# FJL: Resectoscope

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 24
- 510(k) review time 2021–2025: median 261 days (middle half 146–263)
- Recalls: 2 (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)
- 1997: 2
- 2000: 1
- 2004: 1
- 2005: 1
- 2007: 1
- 2010: 1
- 2017: 1
- 2019: 2
- 2023: 2
- 2024: 1

## Most-cited predicates
- K042523: Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 MM, Accessories (2005), cited by 4
- K954050: Resectoscopes (1995), cited by 3
- K162979: Veloxion System (2017), cited by 3
- K971881: Comeg Resectoscope and Laser-Resectoscope Working Elements/Urethrotomes/Electrodes/Albarrab Deflectors (1997), cited by 3
- K041610: Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 (2004), cited by 3
- K190099: Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch (2019), cited by 2
- K904940: Olympus Infant Resectoscope and Accessories (1992), cited by 2
- K001270: Gyrus Endourology System: Axipolar Resectoscope Loop Electrode (2000), cited by 1
- K191341: Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags (2019), cited by 1
- K960757: Karl Storz Ureter Resectoscope (1996), cited by 1

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