FDA 510(k)

密封一次性活體切片閥

K 號：K161167 · 2016-05-26

決定日期2016-05-26

產品代碼OCX

諮詢委員會GU

決定相當於

器材摘要

Seal Single-Use Biopsy Valve is the device name listed in this FDA 510(k) record. The listed applicant is Endochoice, Inc.. It received FDA 510(k) clearance on 2016-05-26 under 510(k) number K161167. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Seal Single-Use Biopsy Valve?

Seal Single-Use Biopsy Valve is a medical device that received FDA 510(k) clearance on 2016-05-26. The listed applicant is Endochoice, Inc.. The 510(k) number is K161167.

When did Seal Single-Use Biopsy Valve receive FDA 510(k) clearance?

Seal Single-Use Biopsy Valve received FDA 510(k) clearance on 2016-05-26, under 510(k) number K161167.

Who is the listed applicant for Seal Single-Use Biopsy Valve?

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 Seal Single-Use Biopsy Valve?

The FDA product code for Seal Single-Use Biopsy Valve is OCX.

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 K160403SmartStart 空氣/水及吸引閥 K153588EndoChoice 水壺蓋系統 K151475EndoChoice Select 注射針

相關器械（代碼：OCX）

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。

K251986輔助水管 MAJ-855Olympus Medical Systems Corporation K251997單次使用病理切片閥 (MAJ-1555)Olympus Medical Systems Corporation K242586ArgoCap (200.52)Ovesco Endoscopy AG K241704內視鏡式水泵Hangzhou AGS MedTech Co., Ltd.K242357水壺（MAJ-901）；水壺（MAJ-902）Olympus Medical Systems Corporation K241874吸引針 (2189)Hobbs Medical, Inc.

官方來源

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