FDA 510(k)

LapBox 조직 격리 제거 시스템

K-번호: K221365 · 2022-08-25

결정일2022-08-25

제품 코드GCJ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

LapBox Tissue Containment Removal System is the device name listed in this FDA 510(k) record. The listed applicant is Ark Surgical, Ltd.. It received FDA 510(k) clearance on 2022-08-25 under 510(k) number K221365. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the LapBox Tissue Containment Removal System?

LapBox Tissue Containment Removal System is a medical device that received FDA 510(k) clearance on 2022-08-25. The listed applicant is Ark Surgical, Ltd.. The 510(k) number is K221365.

When did LapBox Tissue Containment Removal System receive FDA 510(k) clearance?

LapBox Tissue Containment Removal System received FDA 510(k) clearance on 2022-08-25, under 510(k) number K221365.

Who is the listed applicant for LapBox Tissue Containment Removal System?

The FDA 510(k) record lists Ark Surgical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LapBox Tissue Containment Removal System?

The FDA product code for LapBox Tissue Containment Removal System is GCJ.

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LapBox 조직 격리 제거 시스템

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: GCJ)

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