# FHM: Apparatus, Suturing, Stomach And Intestinal

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 2
- 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)
- 1980: 2

## Most-cited predicates
- K801590: Auto Suture Disposable Gia Surg. Stapler (1980), cited by 2
- K801589: Auto Suture Disp. 30, Etc. & Surg. Stap (1980), cited by 1

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