FDA 510(k)

무뎀 트로کار; 날카로운 트로کار; 해슨 트로کار

K-번호: K241052 · 2024-10-04

결정일2024-10-04

제품 코드GCJ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Bladeless Trocar; Bladed Trocar; Hasson Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Advamedix, GmbH. It received FDA 510(k) clearance on 2024-10-04 under 510(k) number K241052. 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 Bladeless Trocar; Bladed Trocar; Hasson Trocar?

Bladeless Trocar; Bladed Trocar; Hasson Trocar is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is Advamedix, GmbH. The 510(k) number is K241052.

When did Bladeless Trocar; Bladed Trocar; Hasson Trocar receive FDA 510(k) clearance?

Bladeless Trocar; Bladed Trocar; Hasson Trocar received FDA 510(k) clearance on 2024-10-04, under 510(k) number K241052.

Who is the listed applicant for Bladeless Trocar; Bladed Trocar; Hasson Trocar?

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

What is the FDA product code for Bladeless Trocar; Bladed Trocar; Hasson Trocar?

The FDA product code for Bladeless Trocar; Bladed Trocar; Hasson Trocar is GCJ.

Advamedix, GmbH를 신청인으로 등재한 기타 기록

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