FDA 510(k)

OverStitch SX內視鏡縫合系統（ESS）

K 號：K171886 · 2017-11-15

決定日期2017-11-15

產品代碼OCW

諮詢委員會GU

決定相當於

器材摘要

OverStitch SX Endoscopic Suturing System (ESS) is the device name listed in this FDA 510(k) record. The listed applicant is Apollo Endosurgery, Inc.. It received FDA 510(k) clearance on 2017-11-15 under 510(k) number K171886. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OverStitch SX Endoscopic Suturing System (ESS)?

OverStitch SX Endoscopic Suturing System (ESS) is a medical device that received FDA 510(k) clearance on 2017-11-15. The listed applicant is Apollo Endosurgery, Inc.. The 510(k) number is K171886.

When did OverStitch SX Endoscopic Suturing System (ESS) receive FDA 510(k) clearance?

OverStitch SX Endoscopic Suturing System (ESS) received FDA 510(k) clearance on 2017-11-15, under 510(k) number K171886.

Who is the listed applicant for OverStitch SX Endoscopic Suturing System (ESS)?

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

What is the FDA product code for OverStitch SX Endoscopic Suturing System (ESS)?

The FDA product code for OverStitch SX Endoscopic Suturing System (ESS) is OCW.

其他以 Apollo Endosurgery, 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。

K232544Apollo ESG NXT 系統, Apollo REVISE NXT 系統 K231553OverStitch NXT內視鏡縫合系統 K210266OverStitch Sx內視鏡縫合系統 K201808X-Tack內視鏡螺旋釘釘系統

相關器械（代碼：OCW）

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。

K252400Endomina EZFuse系統Endo Tools Therapeutics S.A.K243750SimpleStitch 緝合系統Envision Endoscopy K231240MaxTack™ 電動固定裝置Covidien K213271Mediclose™ 系統Health Value Creation B.V., Trading AS Corporis Medical K231553OverStitch NXT內視鏡縫合系統Apollo Endosurgery, Inc.K211309endomina系統Endo Tools Therapeutics S.A.

官方來源

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