# GCM: Endoscope, Rigid

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 18
- 510(k) review time 2021–2025: median 193 days (middle half 193–193)
- 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)
- 1989: 1
- 1990: 1
- 1992: 1
- 1993: 3
- 1995: 2
- 1996: 3
- 1999: 2
- 2000: 1
- 2009: 1
- 2021: 1

## Most-cited predicates
- K203226: Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O 10MM WL 305MM, Telescope 0 O 10MM WL 440MM / Telescope 30 O 10MM WL 440MM / Telescope 50 O 10MM WL 440MM (2021), cited by 2
- K993103: Endoscopes,10MM Diameter 0 Degrees; Endoscopes, 10MM Diameter, 30 Degrees; Endoscopes, 10MM Diameter, 50 Degrees (1999), cited by 1
- K921883: Endoscope (1992), cited by 1
- K955120: Hand-Held Retractor, Dissector & Dissector (1996), cited by 1

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