Cleared Traditional

K261467 - GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)

K261467 is an FDA 510(k) clearance for GT Metabolic Magnet System (MAG-04, manufactured by Gt Metabolic Solutions, Inc.. The device is a Class 2 General & Plastic Surgery device with product code SAH cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K261467 · Gt Metabolic Solutions, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
135d
Days
Class 2
Risk

K261467 is an FDA 510(k) clearance for the GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05,.... Classified as Magnetic Compression Anastomosis System (product code SAH), Class II - Special Controls.

Submitted by Gt Metabolic Solutions, Inc. (St. Michael, US). The FDA issued a Cleared decision on September 16, 2026 after a review of 135 days - within the typical 510(k) review window.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Gt Metabolic Solutions, Inc. devices

FDA 510(k) Submission Details - K261467

510(k) Number K261467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2026
Decision Date September 16, 2026
Days to Decision 135 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 115d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

SAH Device Classification - Class 2, Special Controls

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT06073457 Active not recruiting Interventional Industry-sponsored

Magnetic Gastro-Ileal or Gastro-Jejunal Diversion Study ("MGI/MGJ Study")

Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, GJ Biofragmentable to Achieve Gastro-Ileal or Gastro-Jejunal Diversion in Adults With Obesity

35
Patients (est.)
4
Sites
Treatment
Purpose
Open label
Masking
Condition studied Obesity; Type 2 Diabetes
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor GT Metabolic Solutions, Inc. (industry)
Started 2023-11-06 → Primary completion 2026-04-17 → Completed 2027-01-01
Primary outcome
Magnet Placement
View full study on ClinicalTrials.gov

Regulatory Peers - SAH Magnetic Compression Anastomosis System

All 8
Devices cleared under the same product code (SAH) and FDA review panel - the closest regulatory comparables to K261467.
GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)
K253102 · Gt Metabolic Solutions, Inc. · Jun 2026
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