510(k) K250541

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

August 1, 2025

Date Received

February 24, 2025

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Magnetic Compression Anastomosis System

Device Class

Class II

Regulation Number

878.4816

Review Panel

SU

Submission Type

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