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FDA 510(k)

Self-Forming Magnet (Flexagon Plus OTOLoc)

K-Number: K250541 · 2025-08-01

ApplicantGI Windows, Inc.
Decision Date2025-08-01
Product CodeSAH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Self-Forming Magnet (Flexagon Plus OTOLoc) is the device name listed in this FDA 510(k) record. The listed applicant is GI Windows, Inc.. It received FDA 510(k) clearance on 2025-08-01 under 510(k) number K250541. The device is classified under product code SAH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Self-Forming Magnet (Flexagon Plus OTOLoc)?

Self-Forming Magnet (Flexagon Plus OTOLoc) is a medical device that received FDA 510(k) clearance on 2025-08-01. The listed applicant is GI Windows, Inc.. The 510(k) number is K250541.

When did Self-Forming Magnet (Flexagon Plus OTOLoc) receive FDA 510(k) clearance?

Self-Forming Magnet (Flexagon Plus OTOLoc) received FDA 510(k) clearance on 2025-08-01, under 510(k) number K250541.

Who is the listed applicant for Self-Forming Magnet (Flexagon Plus OTOLoc)?

The FDA 510(k) record lists GI Windows, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Self-Forming Magnet (Flexagon Plus OTOLoc)?

The FDA product code for Self-Forming Magnet (Flexagon Plus OTOLoc) is SAH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06915337Magnet Anastomosis in Patients Undergoing Gastric SurgeryRECRUITINGNCT06915818Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing SurgeryRECRUITINGNCT07276529Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal AnastomosesRECRUITINGNCT07695558Post Market Study of the Flexagon Only System and Flexagon Plus OTOLoc for Creation of Side-to-Side Duodeno-Ileal Diversion & Flexagon Plus OTOLoc Self Forming Magnet (SFM) System for Creation of Side-to-Side Jejunum-Jejunum and Ileal-Ileal AnastomosesNOT_YET_RECRUITINGNCT03130244Procedure for Duodenum to Ileal Diversion to Treat Type 2 DiabetesACTIVE_NOT_RECRUITINGNCT06199635Early Feasibility for Safety & Device Functionality of SFM Anastomosis Device Used in 3 Procedures (SNAP-S) or (SNAP-PS) or (J-J)COMPLETED

Other records listing GI Windows, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253550Self-Forming Magnet (Flexagon Plus OTOLoc)K243482Self-Forming Magnet (Flexagon)K243213Self-Forming Magnet (FLEX SFM)

Related Devices (Code: SAH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253102GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)Gt Metabolic Solutions, Inc.K253550Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc.K243482Self-Forming Magnet (Flexagon)GI Windows, Inc.K243359MagDI System (MAG-02, DS-01)Gt Metabolic Solutions, Inc.K243213Self-Forming Magnet (FLEX SFM)GI Windows, Inc.K242086MagDI System (MAG-01, DS-01)Gt Metabolic Solutions, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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