FDA 510(k)

磁力外科系統

K 號：K252435 · 2025-09-26

決定日期2025-09-26

產品代碼PNL

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

Magnetic Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Levita Magnetics International Corp. It received FDA 510(k) clearance on 2025-09-26 under 510(k) number K252435. The device is classified under product code PNL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Magnetic Surgical System?

Magnetic Surgical System is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is Levita Magnetics International Corp. The 510(k) number is K252435.

When did Magnetic Surgical System receive FDA 510(k) clearance?

Magnetic Surgical System received FDA 510(k) clearance on 2025-09-26, under 510(k) number K252435.

Who is the listed applicant for Magnetic Surgical System?

The FDA 510(k) record lists Levita Magnetics International Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Magnetic Surgical System?

The FDA product code for Magnetic Surgical System is PNL.

其他以 Levita Magnetics International Corp 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。

K250746磁力外科系統 K223673外科控制手臂 K191762磁力外科系統 K190006磁力外科系統 K180894磁力外科系統 K171429磁力外科系統

查看所有 7 項裝置 →

相關器械（代碼：PNL）

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。

K250746磁力外科系統Levita Magnetics International Corp K223673外科控制手臂Levita Magnetics International Corp K191762磁力外科系統Levita Magnetics International Corp K190006磁力外科系統Levita Magnetics International Corp K180894磁力外科系統Levita Magnetics International Corp K171429磁力外科系統Levita Magnetics International Corp

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。