FDA 510(k)

용기성 대장 점막 스타일러, 용기성 내경관 스타일러, 용기성 선형 절단 스타일러, 용기성 내시경 절단 스타일러

K-번호: K211458 · 2021-12-30

신청자Ningbo Verykind Medical Device Co., Ltd.

결정일2021-12-30

제품 코드GDW

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

Ningbo Verykind Medical Device Co., Ltd.를 신청인으로 등재한 기타 기록

K202709용기부동 내시경 선형 절단 스탬퍼 및 카트리지

관련 기기 (코드: GDW)

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