# GCI: Laryngoscope, Endoscope

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 14
- 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)
- 1990: 1
- 1991: 4
- 1992: 2
- 1993: 4
- 2000: 2
- 2002: 1

## Most-cited predicates
- K922123: Auto Suture Disposable Endoscopic Specimen Pouch (1993), cited by 6
- K003222: Modification to Hermes Operating Room Control Center (2000), cited by 2
- K021747: Degall Laparoscopic Gallbladder Extractor (2002), cited by 1
- K001362: Karl Storz 3D Video System (2000), cited by 1

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