FDA 510(k)

GripTract-GI 내시경 조직 조작기

K-번호: K231254 · 2023-11-03

결정일2023-11-03

제품 코드FDF

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

GripTract-GI Endoscopic Tissue Manipulator 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 2023-11-03 under 510(k) number K231254. 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?

GripTract-GI Endoscopic Tissue Manipulator is a medical device that received FDA 510(k) clearance on 2023-11-03. The listed applicant is Actuated Medical, Inc.. The 510(k) number is K231254.

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

GripTract-GI Endoscopic Tissue Manipulator received FDA 510(k) clearance on 2023-11-03, under 510(k) number K231254.

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

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?

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

Actuated Medical, Inc.를 신청인으로 등재한 기타 기록

K251041GripTract-GI™ 내시경 조직 조작기 상위 대장 모델 GT-GS100 K242325GripTract-GI 내시경 조직 조작기 하위 대장 모델 K220890IO 주사기 안전 씻기 K200646tubeClear 시스템 K172556tubeClear 시스템 K163092tubeClear 제어 상자 및 청소 스틱

7개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.