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Panels › General, Plastic Surgery › Product code SAH · Class 2

Magnetic Compression Anastomosis System

Regulation 878.4816

3510(k)s in 12 months (9 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in SAH

Company510(k)sRecalls
Gt Metabolic Solutions, Inc.50
GI Windows, Inc.40
Decided510(k)Device and applicantCode
Sep 16, 2026K261467GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)
Gt Metabolic Solutions, Inc.
SAH
Jun 4, 2026K253102GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)
Gt Metabolic Solutions, Inc.
SAH
Jan 9, 2026K253550Self-Forming Magnet (Flexagon Plus OTOLoc)
GI Windows, Inc.
SAH
Aug 1, 2025K250541Self-Forming Magnet (Flexagon Plus OTOLoc)
GI Windows, Inc.
SAH
Jun 11, 2025K243482Self-Forming Magnet (Flexagon)
GI Windows, Inc.
SAH
Feb 28, 2025K243359MagDI System (MAG-02, DS-01)
Gt Metabolic Solutions, Inc.
SAH
Jan 29, 2025K243213Self-Forming Magnet (FLEX SFM)
GI Windows, Inc.
SAH
Oct 24, 2024K242086MagDI System (MAG-01, DS-01)
Gt Metabolic Solutions, Inc.
SAH
Jul 2, 2024DEN240013MagDI System
Gt Metabolic Solutions, Inc.
SAH

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