# GDH: Gouge, Surgical, General & Plastic Surgery

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 6
- 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)
- 1976: 1
- 1984: 1
- 1987: 1
- 1989: 1
- 1990: 2

## Most-cited predicates
- K903419: Modified Surgiport Disposable Trocar and Sleeve (1990), cited by 6
- K874879: Auto Suture (R) Surgiport Dispos Surg Trocar/Sleeve (1987), cited by 1
- K900487: Modified Auto Suture Surgiport Trocar & Sleeve (1990), cited by 1

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