FDA 510(k)

GripTract-GI 내시경 조직 조작기 하위 대장 모델

K-번호: K242325 · 2024-10-04

결정일2024-10-04

제품 코드FDF

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

GripTract-GI Endoscopic Tissue Manipulator Lower GI Models is the device name listed in this FDA 510(k) record. The listed applicant is Actuated Medical, Inc.. It received FDA 510(k) clearance on 2024-10-04 under 510(k) number K242325. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the GripTract-GI Endoscopic Tissue Manipulator Lower GI Models?

GripTract-GI Endoscopic Tissue Manipulator Lower GI Models is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is Actuated Medical, Inc.. The 510(k) number is K242325.

When did GripTract-GI Endoscopic Tissue Manipulator Lower GI Models receive FDA 510(k) clearance?

GripTract-GI Endoscopic Tissue Manipulator Lower GI Models received FDA 510(k) clearance on 2024-10-04, under 510(k) number K242325.

Who is the listed applicant for GripTract-GI Endoscopic Tissue Manipulator Lower GI Models?

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

What is the FDA product code for GripTract-GI Endoscopic Tissue Manipulator Lower GI Models?

The FDA product code for GripTract-GI Endoscopic Tissue Manipulator Lower GI Models is FDF.

Actuated Medical, Inc.를 신청인으로 등재한 기타 기록

K251041GripTract-GI™ 내시경 조직 조작기 상위 대장 모델 GT-GS100 K231254GripTract-GI 내시경 조직 조작기 K220890IO 주사기 안전 씻기 K200646tubeClear 시스템 K172556tubeClear 시스템 K163092tubeClear 제어 상자 및 청소 스틱

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