FDA 510(k)

Multi-Functional Electrosurgical Knife

K-번호: K212999 · 2022-03-21

결정일2022-03-21

제품 코드KNS

자문 위원회GU

결정Substantially Equivalent

기기 요약

Multi-Functional Electrosurgical Knife is the device name listed in this FDA 510(k) record. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2022-03-21 under 510(k) number K212999. 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 Multi-Functional Electrosurgical Knife?

Multi-Functional Electrosurgical Knife is a medical device that received FDA 510(k) clearance on 2022-03-21. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. The 510(k) number is K212999.

When did Multi-Functional Electrosurgical Knife receive FDA 510(k) clearance?

Multi-Functional Electrosurgical Knife received FDA 510(k) clearance on 2022-03-21, under 510(k) number K212999.

Who is the listed applicant for Multi-Functional Electrosurgical Knife?

The FDA 510(k) record lists Anrei Medical (Hangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multi-Functional Electrosurgical Knife?

The FDA product code for Multi-Functional Electrosurgical Knife is KNS.

Anrei Medical (Hangzhou) Co., Ltd.를 신청인으로 등재한 기타 기록

K210917Single Use Injection Needle K202987Rescue Pulmonary Grasping Forceps K210660Stone Retrieval Balloon Catheter K201771Single Use Rotatable and Repositionable Hemoclip K192048Single Use Endoscope Valves Set

공식 출처

FDA 데이터베이스에서 보기 →

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