FDA 510(k)

自形成磁铁（Flexagon Plus OTOLoc）

K号: K253550 · 2026-01-09

决定日期2026-01-09

产品代码SAH

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决定实质等同

器械摘要

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 2026-01-09 under 510(k) number K253550. The device is classified under product code SAH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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. The listed applicant is GI Windows, Inc.. The 510(k) number is K253550.

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 2026-01-09, under 510(k) number K253550.

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.

列明GI Windows, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250541自形成磁铁（Flexagon Plus OTOLoc）K243482自形成磁铁（Flexagon）K243213自形成磁铁（FLEX SFM）

官方来源

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