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FDA 510(k)

ReShape校準管(B-2032、B-2036、B-2040);ReShape校準管(B-2017);胃球吸引針(B-2020)

K 號:K241039 · 2024-05-16

決定日期2024-05-16
產品代碼KNT
諮詢委員會GU
決定相當於

器材摘要

ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) is the device name listed in this FDA 510(k) record. The listed applicant is Reshape Lifesciences. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K241039. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)?

ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is Reshape Lifesciences. The 510(k) number is K241039.

When did ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) receive FDA 510(k) clearance?

ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) received FDA 510(k) clearance on 2024-05-16, under 510(k) number K241039.

Who is the listed applicant for ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)?

The FDA 510(k) record lists Reshape Lifesciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)?

The FDA product code for ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) is KNT.

相關臨床試驗

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其他以 Reshape Lifesciences 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。

相關器械(代碼:KNT)

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。

官方來源

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