FDA 510(k)

Aliya® EX 系統；Aliya® EX 產生器；Aliya® 尖針；Aliya® 電極；INUMI™ 強韌針

K 號：K253826 · 2026-05-07

決定日期2026-05-07

產品代碼OAB

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle is the device name listed in this FDA 510(k) record. The listed applicant is Galvanize Therapeutics, Inc.. It received FDA 510(k) clearance on 2026-05-07 under 510(k) number K253826. The device is classified under product code OAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle?

Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle is a medical device that received FDA 510(k) clearance on 2026-05-07. The listed applicant is Galvanize Therapeutics, Inc.. The 510(k) number is K253826.

When did Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle receive FDA 510(k) clearance?

Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle received FDA 510(k) clearance on 2026-05-07, under 510(k) number K253826.

Who is the listed applicant for Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle?

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

What is the FDA product code for Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle?

The FDA product code for Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle is OAB.

其他以 Galvanize Therapeutics, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K233884INUMI™ 強針 K212871Aliya™ 系統，Aliya™ 產生器，Aliya™ 尖針，Aliya™ 電極

相關器械（代碼：OAB）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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