Cleared Traditional

K250541 - Self-Forming Magnet (Flexagon Plus OTOLoc) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250541 · GI Windows, Inc. · General & Plastic Surgery device
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Aug 2025
Decision
158d
Days
Class 2
Risk

K250541 is an FDA 510(k) clearance for the Self-Forming Magnet (Flexagon Plus OTOLoc). Classified as Magnetic Compression Anastomosis System (product code SAH), Class II - Special Controls.

Submitted by GI Windows, Inc. (Westwood, US). The FDA issued a Cleared decision on August 1, 2025 after a review of 158 days - an extended review cycle.

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 GI Windows, Inc. devices

Submission Details

510(k) Number K250541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2025
Decision Date August 01, 2025
Days to Decision 158 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
44d slower than avg
Panel avg: 114d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K250541.
Self-Forming Magnet (Flexagon Plus OTOLoc)
K253550 · GI Windows, Inc. · Jan 2026
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
MagDI System
DEN240013 · Gt Metabolic Solutions, Inc. · Jul 2024