FDA 510(k)

에소피엡 Z+ 장비 및 세로사푸스 패치와 액세서리

K-번호: K240879 · 2024-04-26

결정일2024-04-26

제품 코드ODE

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Endogastric Solutions, Inc.. It received FDA 510(k) clearance on 2024-04-26 under 510(k) number K240879. The device is classified under product code ODE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the EsophyX Z+ Device with SerosaFuse Fasteners and Accessories?

EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is a medical device that received FDA 510(k) clearance on 2024-04-26. The listed applicant is Endogastric Solutions, Inc.. The 510(k) number is K240879.

When did EsophyX Z+ Device with SerosaFuse Fasteners and Accessories receive FDA 510(k) clearance?

EsophyX Z+ Device with SerosaFuse Fasteners and Accessories received FDA 510(k) clearance on 2024-04-26, under 510(k) number K240879.

Who is the listed applicant for EsophyX Z+ Device with SerosaFuse Fasteners and Accessories?

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

What is the FDA product code for EsophyX Z+ Device with SerosaFuse Fasteners and Accessories?

The FDA product code for EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is ODE.

Endogastric Solutions, Inc.를 신청인으로 등재한 기타 기록

K172811에소피엡 Z, 에소피엡2 HD K171307EsophyX2 HD 장치와 SerosaFuse 고정장치 및 액세서리, EsophyX Z 장치와 SerosaFuse 고정장치 및 액세서리 K160960에소피엡® Z 장치와 세로사푸스 패치 및 액세서리

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