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510(k) DEN240013

MagDI System by Gt Metabolic Solutions, Inc. — Product Code SAH

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
July 2, 2024
Date Received
March 26, 2024
Clearance Type
Post-NSE
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

Other clearances by Gt Metabolic Solutions, Inc.

  • K243359 — MagDI System (MAG-02, DS-01) (February 28, 2025)
  • K242086 — MagDI System (MAG-01, DS-01) (October 24, 2024)

Other clearances for product code SAH

  • K253550 — Self-Forming Magnet (Flexagon Plus OTOLoc) (January 9, 2026)
  • K250541 — Self-Forming Magnet (Flexagon Plus OTOLoc) (August 1, 2025)
  • K243482 — Self-Forming Magnet (Flexagon) (June 11, 2025)
  • K243359 — MagDI System (MAG-02, DS-01) (February 28, 2025)
  • K243213 — Self-Forming Magnet (FLEX SFM) (January 29, 2025)
  • K242086 — MagDI System (MAG-01, DS-01) (October 24, 2024)