# FGA: Kit, Nephroscope

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 267 days (middle half 267–267)
- Recalls: 0 (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)
- 1977: 1
- 1979: 1
- 1985: 1
- 1993: 1
- 1994: 1
- 1995: 1
- 2000: 1
- 2007: 1
- 2016: 1
- 2024: 1

## Most-cited predicates
- K994223: Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope, 20 Degree, Straight View; Nephroscope, 20 (2000), cited by 3
- K151308: Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set (2016), cited by 1
- K922826: Flexible Fiber Optic Endoscope (1993), cited by 1
- K072594: Gyrus Acmi Ipn-2505, Invisio  Smith Percutaneous  Nephroscope System (2007), cited by 1
- K791182: Acmi Rigi-Flex Nephorscope (1979), cited by 1
- K770729: Pyeloscope System (1977), cited by 1
- K940594: Karl Storz Adult & Pediatric Nephroscope (1994), cited by 1

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