Cleared Traditional

K261630 - GI Windows Flexagon Plus OTOLoc System

K261630 is an FDA 510(k) clearance for GI Windows Flexagon Plus OTOLoc System, manufactured by GI Windows Surgical. The device is a Class 2 General & Plastic Surgery device with product code SAH cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K261630 · GI Windows Surgical · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
163d
Days
Class 2
Risk

K261630 is an FDA 510(k) clearance for the GI Windows Flexagon Plus OTOLoc System. Classified as Magnetic Compression Anastomosis System (product code SAH), Class II - Special Controls.

Submitted by GI Windows Surgical (Canton, US). The FDA issued a Cleared decision on October 28, 2026 after a review of 163 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.

FDA 510(k) Submission Details - K261630

510(k) Number K261630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2026
Decision Date October 28, 2026
Days to Decision 163 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
48d slower than avg
Panel avg: 115d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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

All 9
Devices cleared under the same product code (SAH) and FDA review panel - the closest regulatory comparables to K261630.
GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)
K261467 · Gt Metabolic Solutions, Inc. · Sep 2026
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
K261630 · GI Windows Flexagon Plus OTOLoc System
Download PDF FDA Summary GI Windows Surgical