FDA 510(k)

單次使用抽提籃

K 號：K240192 · 2024-10-15

決定日期2024-10-15

產品代碼LQR

諮詢委員會GU

決定相當於

器材摘要

Single-use Extraction Baskets is the device name listed in this FDA 510(k) record. The listed applicant is Scivita Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-10-15 under 510(k) number K240192. The device is classified under product code LQR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Single-use Extraction Baskets?

Single-use Extraction Baskets is a medical device that received FDA 510(k) clearance on 2024-10-15. The listed applicant is Scivita Medical Technology Co., Ltd.. The 510(k) number is K240192.

When did Single-use Extraction Baskets receive FDA 510(k) clearance?

Single-use Extraction Baskets received FDA 510(k) clearance on 2024-10-15, under 510(k) number K240192.

Who is the listed applicant for Single-use Extraction Baskets?

FDA 510(k) 記錄將 Scivita Medical Technology Co., Ltd. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Single-use Extraction Baskets?

The FDA product code for Single-use Extraction Baskets is LQR.

其他以 Scivita Medical Technology Co., Ltd. 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。

K262552單次使用柔軟輸尿管鏡（單次使用柔軟輸尿管鏡：SUV-5C-B）K251338肝管內視鏡視覺化系統（一次性視覺肝管內視鏡：SCV-P-01G，SCV-P-02G；全高清內視鏡影像處理器：HDVS-S300A，HDVS-S300B，HDVS-S300C，HDVS-S300D）K243708泌尿內視鏡系統（單次使用柔軟輸尿管鏡：SUV-1A-B、SUV-1A-P、SUV-2A-B、SUV-2A-P、SUV-2B-B、SUB-2B-P、SUV-2C-B、SUV-2C-P；單次使用柔軟膀胱鏡：SUV-1D-B、SUV-1D-P；內視鏡圖像處理器：HDVS-S100A、HDVS-S100D。）K250210bronchovideoscope系統（單次使用支氣管內視鏡（SBV-1A-B、SBV-1A-P、SBV-1B-B、SBV-1B-P、SBV-1C-B、SBV-1C-P）；全高清內視鏡影像處理器（HDVS-S300A、HDVS-S300B、HDVS-S300C、HDVS-S300D）；內視鏡影像處理器（HDVS-S100A、HDVS-S100D））K240289全高清內視鏡影像處理器（HDVS-S200A、HDVS-S200B、HDVS-S200C、HDVS-S200D）K231521bronchovideoscope 系統

查看所有 13 項裝置 →

相關器械（代碼：LQR）

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。

K253056一次性石塊取出籃Zhejiang Soudon Medical Technology Co., Ltd.K243807單次使用回收籃 V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp.K243471抽獲籃Micro-Tech (Nanjing) Co., Ltd.K230598石頭提取籃Jiangsu Vedkang Medical Science and Technology Co., Ltd.K203322SpyGlass Discover 回收籃Boston Scientific Corporation K201509一次性石塊取出籃Hangzhou AGS MedTech Co., Ltd.

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。