FDA 510(k)

CiRX 일회용 전기수술 펜셀, 비포장 및 포장电极

K-번호: K213786 · 2022-06-27

결정일2022-06-27

제품 코드GEI

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

CiRX Single use electrosurgical pencil with non-coated and coated electrode is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Shun YE Medical Company, Ltd.. It received FDA 510(k) clearance on 2022-06-27 under 510(k) number K213786. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the CiRX Single use electrosurgical pencil with non-coated and coated electrode?

CiRX Single use electrosurgical pencil with non-coated and coated electrode is a medical device that received FDA 510(k) clearance on 2022-06-27. The listed applicant is Ningbo Shun YE Medical Company, Ltd.. The 510(k) number is K213786.

When did CiRX Single use electrosurgical pencil with non-coated and coated electrode receive FDA 510(k) clearance?

CiRX Single use electrosurgical pencil with non-coated and coated electrode received FDA 510(k) clearance on 2022-06-27, under 510(k) number K213786.

Who is the listed applicant for CiRX Single use electrosurgical pencil with non-coated and coated electrode?

The FDA 510(k) record lists Ningbo Shun YE Medical Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CiRX Single use electrosurgical pencil with non-coated and coated electrode?

The FDA product code for CiRX Single use electrosurgical pencil with non-coated and coated electrode is GEI.

Ningbo Shun YE Medical Company, Ltd.를 신청인으로 등재한 기타 기록

K210256CiRx (R) 수술용 마스크

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