FDA 510(k)

LiftUp (參考編號：200.56.01)，LiftUp 套件（參考編號：200.56.02）

K 號：K221385 · 2022-08-11

決定日期2022-08-11

產品代碼PLL

諮詢委員會GU

決定相當於

器材摘要

LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) is the device name listed in this FDA 510(k) record. The listed applicant is Ovesco Endoscopy AG. It received FDA 510(k) clearance on 2022-08-11 under 510(k) number K221385. The device is classified under product code PLL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)?

LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) is a medical device that received FDA 510(k) clearance on 2022-08-11. The listed applicant is Ovesco Endoscopy AG. The 510(k) number is K221385.

When did LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) receive FDA 510(k) clearance?

LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) received FDA 510(k) clearance on 2022-08-11, under 510(k) number K221385.

Who is the listed applicant for LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)?

FDA 510(k) 記錄將 Ovesco Endoscopy AG 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)?

The FDA product code for LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) is PLL.

其他以 Ovesco Endoscopy AG 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。

K253481結腸FTRD組合（200.70）；診斷FTRD組合（200.76）；胃十二指腸FTRD組合（200.72）K251562OTSCneo 系統組合（100.03n-14n，100.27n-31n）K242586ArgoCap (200.52)K241858BARS Set (100.60)K200684胃十二指腸FTRD 設備集 K183309stentfix OTSC 系統組合

查看所有 9 項裝置 →

相關器械（代碼：PLL）

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。

K260997SIS BLU (SISBLU-30-01)；SIS BLU (SISBLU-15-01)Endoclot Plus Co., Ltd.K241591藍眼The Standard Co., Ltd.K220434藍眼 (TS-905)The Standard Co., Ltd.K200071藍光信標黏膜注射溶液Micro-Tech (Nanjing) Co., Ltd.K202376永昇黏膜提升劑Gi Supply, Inc.K191923永昇黏膜提升劑Gi Supply

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。