FDA 510(k)

전기수술 시스템 (이중극 피로젬형 수술 도구와 일회용 전기수술 낫 결합된 전기수술 발생기)

K-번호: K192342 · 2020-05-21

결정일2020-05-21

제품 코드KNS

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AGS MedTech Co., Ltd.. It received FDA 510(k) clearance on 2020-05-21 under 510(k) number K192342. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)?

Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) is a medical device that received FDA 510(k) clearance on 2020-05-21. The listed applicant is Hangzhou AGS MedTech Co., Ltd.. The 510(k) number is K192342.

When did Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) receive FDA 510(k) clearance?

Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) received FDA 510(k) clearance on 2020-05-21, under 510(k) number K192342.

Who is the listed applicant for Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)?

FDA 510(k) 기록은 상하이 AGS MedTech Co., Ltd.를 신청자로 나열하고 있습니다. 이는 단순히 장비 제조업체를 확정하는 것은 아닙니다.

What is the FDA product code for Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)?

The FDA product code for Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) is KNS.