Not Cleared Post-NSE

DEN240013 - MagDI System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN240013 · Gt Metabolic Solutions, Inc. · General & Plastic Surgery device
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Jul 2024
Decision
98d
Days
Class 2
Risk

DEN240013 is an FDA 510(k) submission (not cleared) for the MagDI System. Classified as Magnetic Compression Anastomosis System (product code SAH), Class II - Special Controls.

Submitted by Gt Metabolic Solutions, Inc. (San Jose, US). The FDA issued a Not Cleared (DENG) decision on July 2, 2024 after a review of 98 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4816 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the General & Plastic Surgery review framework.

View all Gt Metabolic Solutions, Inc. devices

Submission Details

510(k) Number DEN240013 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 26, 2024
Decision Date July 02, 2024
Days to Decision 98 days
Submission Type Post-NSE
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 114d · This submission: 98d
Pathway characteristics

Device Classification

Product Code SAH Magnetic Compression Anastomosis System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4816
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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - SAH Magnetic Compression Anastomosis System

Devices cleared under the same product code (SAH) and FDA review panel - the closest regulatory comparables to DEN240013.
Self-Forming Magnet (Flexagon Plus OTOLoc)
K253550 · GI Windows, Inc. · Jan 2026
Self-Forming Magnet (Flexagon Plus OTOLoc)
K250541 · GI Windows, Inc. · Aug 2025
Self-Forming Magnet (Flexagon)
K243482 · GI Windows, Inc. · Jun 2025
MagDI System (MAG-02, DS-01)
K243359 · Gt Metabolic Solutions, Inc. · Feb 2025
Self-Forming Magnet (FLEX SFM)
K243213 · GI Windows, Inc. · Jan 2025
MagDI System (MAG-01, DS-01)
K242086 · Gt Metabolic Solutions, Inc. · Oct 2024