SAH · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4816
Classification
FDA Product Code
SAH
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4816
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A magnetic compression anastomosis system is a surgical device used for the creation of anastomoses in minimally invasive and laparoscopic surgery in the gastrointestinal tract. The system is comprised of magnet devices and may involve a delivery system. Compression and necrosis of tissue between magnet devices is created by polar attraction of the magnet devices with healing of tissue around the devices. Once the anastomosis is formed, the magnet devices are expelled naturally. This classification does not include devices intended for weight loss or metabolic disease treatment