Self-Forming Magnet (FLEX SFM)
K-Number: K243213 · 2025-01-29
ApplicantGI Windows, Inc.
Decision Date2025-01-29
Product CodeSAH
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Self-Forming Magnet (FLEX SFM) is a medical device manufactured by GI Windows, Inc.. It received FDA 510(k) clearance on 2025-01-29 under approval number K243213. 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 (FLEX SFM)?
Self-Forming Magnet (FLEX SFM) is a medical device that received FDA 510(k) clearance on 2025-01-29. It is manufactured by GI Windows, Inc.. The 510(k) number is K243213.
When was Self-Forming Magnet (FLEX SFM) approved by the FDA?
Self-Forming Magnet (FLEX SFM) received FDA 510(k) clearance on 2025-01-29, under approval number K243213.
What company makes Self-Forming Magnet (FLEX SFM)?
Self-Forming Magnet (FLEX SFM) is manufactured by GI Windows, Inc..
What is the FDA product code for Self-Forming Magnet (FLEX SFM)?
The FDA product code for Self-Forming Magnet (FLEX SFM) is SAH.
Other Devices by GI Windows, Inc.
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K243359MagDI System (MAG-02, DS-01)Gt Metabolic Solutions, Inc.
K253550Self-Forming Magnet (Flexagon Plus OTOLoc)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.