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FDA PRODUCT CODE · CLASS II

SAHMagnetic Compression Anastomosis System

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

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4816
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
ImplantLife-sustainingGMP-exemptThird-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES

Recent clearances

K253102Gt Metabolic Solutions, Inc. · 510k2026-06-04
K253550GI Windows, Inc. · 510k2026-01-09
K250541GI Windows, Inc. · 510k2025-08-01
K243482GI Windows, Inc. · 510k2025-06-11
K243359Gt Metabolic Solutions, Inc. · 510k2025-02-28
K243213GI Windows, Inc. · 510k2025-01-29
K242086Gt Metabolic Solutions, Inc. · 510k2024-10-24

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA enforcement & recalls

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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