FDA 510(k)

SmartStart 空氣/水及吸引閥

K 號：K160403 · 2016-05-19

決定日期2016-05-19

產品代碼ODC

諮詢委員會GU

決定相當於

器材摘要

SmartStart Air/Water and Suction Valves is the device name listed in this FDA 510(k) record. The listed applicant is Endochoice, Inc.. It received FDA 510(k) clearance on 2016-05-19 under 510(k) number K160403. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SmartStart Air/Water and Suction Valves?

SmartStart Air/Water and Suction Valves is a medical device that received FDA 510(k) clearance on 2016-05-19. The listed applicant is Endochoice, Inc.. The 510(k) number is K160403.

When did SmartStart Air/Water and Suction Valves receive FDA 510(k) clearance?

SmartStart Air/Water and Suction Valves received FDA 510(k) clearance on 2016-05-19, under 510(k) number K160403.

Who is the listed applicant for SmartStart Air/Water and Suction Valves?

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

What is the FDA product code for SmartStart Air/Water and Suction Valves?

The FDA product code for SmartStart Air/Water and Suction Valves is ODC.

其他以 Endochoice, Inc. 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。

K160275融合內視鏡系統搭配FuseBox處理器 K161482EndoChoice 水壺蓋灌流系統 K161167密封一次性活體切片閥 K153588EndoChoice 水壺蓋系統 K151475EndoChoice Select 注射針

相關器械（代碼：ODC）

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。

K252933DYNE PORTDyne Medical Group, Inc.K250145組織切片端口轉接器Endosound, Inc.K252910Orca 空氣/水及吸引閥Boston Scientific K250949吸引閥 (MAJ-1443)；空氣/水閥 (MAJ-1444)Olympus Medical Systems Corporation K250732一次性內視鏡閥門組Yangzhou Fartley Medical Instrument Technology Co., Ltd.K241842路氏分離 MAJ-2092Olympus Medical Systems Corporation

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