FDA 510(k)

내시경 라인어닝 스타일러 및 일회용 로드 유닛

K-번호: K181620 · 2018-09-18

결정일2018-09-18

제품 코드GDW

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

결정대체적으로 동일

기기 요약

Endoscopic Linear Cutting Staplers and Loading Units for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Ezisurg (Suzhou) Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-09-18 under 510(k) number K181620. 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 Endoscopic Linear Cutting Staplers and Loading Units for Single Use?

Endoscopic Linear Cutting Staplers and Loading Units for Single Use is a medical device that received FDA 510(k) clearance on 2018-09-18. The listed applicant is Ezisurg (Suzhou) Medical Co., Ltd.. The 510(k) number is K181620.

When did Endoscopic Linear Cutting Staplers and Loading Units for Single Use receive FDA 510(k) clearance?

Endoscopic Linear Cutting Staplers and Loading Units for Single Use received FDA 510(k) clearance on 2018-09-18, under 510(k) number K181620.

Who is the listed applicant for Endoscopic Linear Cutting Staplers and Loading Units for Single Use?

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

What is the FDA product code for Endoscopic Linear Cutting Staplers and Loading Units for Single Use?

The FDA product code for Endoscopic Linear Cutting Staplers and Loading Units for Single Use is GDW.

Ezisurg (Suzhou) Medical Co., Ltd.를 신청인으로 등재한 기타 기록

K182217일회용 라인어터 스탬퍼 및 로딩 유닛, 일회용 원형 스탬퍼

관련 기기 (코드: GDW)

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