FDA 510(k)

達針

K 號：K240253 · 2024-03-21

決定日期2024-03-21

產品代碼BSP

諮詢委員會AN

決定相當於

器材摘要

Reach Needle is the device name listed in this FDA 510(k) record. The listed applicant is Aerin Medical, Inc.. It received FDA 510(k) clearance on 2024-03-21 under 510(k) number K240253. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Reach Needle?

Reach Needle is a medical device that received FDA 510(k) clearance on 2024-03-21. The listed applicant is Aerin Medical, Inc.. The 510(k) number is K240253.

When did Reach Needle receive FDA 510(k) clearance?

Reach Needle received FDA 510(k) clearance on 2024-03-21, under 510(k) number K240253.

Who is the listed applicant for Reach Needle?

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

What is the FDA product code for Reach Needle?

The FDA product code for Reach Needle is BSP.

其他以 Aerin Medical, Inc. 為申請人之記錄

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K260522RhinAer+筆尖 K242630Aerin 控制台 K221907RhinAer®筆 (FG1393)K200300VivAer筆 K192471RHIN1筆尖 K172529Vivaer ARC筆尖

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相關器械（代碼：BSP）

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。

K243690SonoMSKPAJUNK GmbH Medizintechnologie K243682SonoPlex STIM；SonoPlex IIPAJUNK GmbH Medizintechnologie K250774SPROTTE® 标準 (LUER/NRFit®) 腰椎穿刺PAJUNK GmbH Medizintechnologie K243525SonoTAP 及 SonoTAP IIPAJUNK GmbH Medizintechnologie K241953SPROTTE®標準（LUER/NRFit®）麻醉學PAJUNK GmbH Medizintechnologie K241954SonoBlock；SonoBlock IIPAJUNK GmbH Medizintechnologie

官方來源

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