FDA 510(k)

AdvanCE 캡슐 엔도스코프 전달 장치

K-번호: K163495 · 2017-03-10

결정일2017-03-10

제품 코드NEZ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

AdvanCE capsule endoscope delivery device is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2017-03-10 under 510(k) number K163495. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the AdvanCE capsule endoscope delivery device?

AdvanCE capsule endoscope delivery device is a medical device that received FDA 510(k) clearance on 2017-03-10. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K163495.

When did AdvanCE capsule endoscope delivery device receive FDA 510(k) clearance?

AdvanCE capsule endoscope delivery device received FDA 510(k) clearance on 2017-03-10, under 510(k) number K163495.

Who is the listed applicant for AdvanCE capsule endoscope delivery device?

The FDA 510(k) record lists United States Endoscopy Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AdvanCE capsule endoscope delivery device?

The FDA product code for AdvanCE capsule endoscope delivery device is NEZ.

United States Endoscopy Group, Inc.를 신청인으로 등재한 기타 기록

K192265gi-4000 Electrosurgical Generator K200745라리어트, 핫/콜드 스네어 K192059바이오가드 에어/워터 & 수술 밸브 K191559AquaShield 시스템 CO2, AquaShield 시스템 CO2-PENTAX, AquaShield 시스템 CO2-FUJIFILM K182909Roth Net Retriever Product Line K182258AquaShield 시스템 CO2 ; AquaShield 시스템 CO2 - PENTAX ; AquaShield 시스템 CO2 - Fujifilm

10개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

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