Self-Forming Magnet (Flexagon Plus OTOLoc)
K-Number: K253550 · 2026-01-09
ApplicantGI Windows, Inc.
Decision Date2026-01-09
Product CodeSAH
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Self-Forming Magnet (Flexagon Plus OTOLoc) is a medical device manufactured by GI Windows, Inc.. It received FDA 510(k) clearance on 2026-01-09 under approval number K253550. 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 2026-01-09. It is manufactured by GI Windows, Inc.. The 510(k) number is K253550.
When was Self-Forming Magnet (Flexagon Plus OTOLoc) approved by the FDA?
Self-Forming Magnet (Flexagon Plus OTOLoc) received FDA 510(k) clearance on 2026-01-09, under approval number K253550.
What company makes Self-Forming Magnet (Flexagon Plus OTOLoc)?
Self-Forming Magnet (Flexagon Plus OTOLoc) is manufactured by GI Windows, Inc..
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
Other Devices by GI Windows, Inc.
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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.
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.