# SAH: Magnetic Compression Anastomosis System

- Device class: 2; regulation: 21 CFR 878.4816; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 122 days (middle half 118–158)
- 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)
- 2024: 2
- 2025: 4
- 2026: 3

## Most-cited predicates
- K242086: MagDI System (MAG-01, DS-01) (2024), cited by 3
- DEN240013: MagDI System (2024), cited by 2
- K243359: MagDI System (MAG-02, DS-01) (2025), cited by 2
- K243213: Self-Forming Magnet (FLEX SFM) (2025), cited by 1
- K250541: Self-Forming Magnet (Flexagon Plus OTOLoc) (2025), cited by 1
- K243482: Self-Forming Magnet (Flexagon) (2025), cited by 1
- K253102: GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) (2026), cited by 1

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