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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device magnetic compression anastomosis system
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
Product CodeSAH
Regulation Number 878.4816
Device Class 2


Premarket Reviews
ManufacturerDecision
GI WINDOWS, INC.
  SUBSTANTIALLY EQUIVALENT 4
GT METABOLIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
  GRANTED 1

MDR Year MDR Reports MDR Events
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure to Anastomose 1 1

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