FDA 510(k)

一次性肛門肛門釘合器、一次性內腔釘合器、一次性線性切割釘合器、一次性內視鏡切割釘合器

K 號：K211458 · 2021-12-30

申請人Ningbo Verykind Medical Device Co., Ltd.

決定日期2021-12-30

產品代碼GDW

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Verykind Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2021-12-30 under 510(k) number K211458. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers?

Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers is a medical device that received FDA 510(k) clearance on 2021-12-30. The listed applicant is Ningbo Verykind Medical Device Co., Ltd.. The 510(k) number is K211458.

When did Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers receive FDA 510(k) clearance?

Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers received FDA 510(k) clearance on 2021-12-30, under 510(k) number K211458.

Who is the listed applicant for Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers?

The FDA 510(k) record lists Ningbo Verykind Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers?

The FDA product code for Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers is GDW.

其他以 Ningbo Verykind Medical Device 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。

K202709一次性電動內視鏡線性切釘器及彈藥

相關器械（代碼：GDW）

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。

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。