FDA 510(k)

Boston 2910 (Boston 2910)

K号: K253245 · 2026-05-21

决定日期2026-05-21

产品代码GEX

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决定实质等同

器械摘要

Boston 2910 (Boston 2910) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Aesthetics, Inc.. It received FDA 510(k) clearance on 2026-05-21 under 510(k) number K253245. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the Boston 2910 (Boston 2910)?

Boston 2910 (Boston 2910) is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is Boston Aesthetics, Inc.. The 510(k) number is K253245.

When did Boston 2910 (Boston 2910) receive FDA 510(k) clearance?

Boston 2910 (Boston 2910) received FDA 510(k) clearance on 2026-05-21, under 510(k) number K253245.

Who is the listed applicant for Boston 2910 (Boston 2910)?

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

What is the FDA product code for Boston 2910 (Boston 2910)?

The FDA product code for Boston 2910 (Boston 2910) is GEX. This falls under the Gastroenterology category.

列明Boston Aesthetics, 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。

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