FDA 510(k)

용기 Endoscopic 스타일러 및 재충전 단위, 용기 혈관절절 스타일러, 용기 선형 절단 스타일러, 용기 원형 스타일러

K-번호: K211811 · 2022-03-03

결정일2022-03-03

제품 코드GDW

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

결정대체적으로 동일

기기 요약

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Beien Surgery Device Co., Ltd.. It received FDA 510(k) clearance on 2022-03-03 under 510(k) number K211811. 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 Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers?

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers is a medical device that received FDA 510(k) clearance on 2022-03-03. The listed applicant is Wuxi Beien Surgery Device Co., Ltd.. The 510(k) number is K211811.

When did Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers receive FDA 510(k) clearance?

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers received FDA 510(k) clearance on 2022-03-03, under 510(k) number K211811.

Who is the listed applicant for Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers?

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

What is the FDA product code for Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers?

The FDA product code for Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers is GDW.

관련 기기 (코드: GDW)

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: GDW)

공식 출처