FDA 510(k)

용기 Endoscopic 수술 도구, 재사용 가능 Endoscopic 수술 도구

K-번호: K171825 · 2018-02-13

신청자Hunan Handlike Minimally Invasive Surgery Co., Ltd.

결정일2018-02-13

제품 코드GEI

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

결정대체적으로 동일

기기 요약

Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Handlike Minimally Invasive Surgery Co., Ltd.. It received FDA 510(k) clearance on 2018-02-13 under 510(k) number K171825. 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 Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument?

Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument is a medical device that received FDA 510(k) clearance on 2018-02-13. The listed applicant is Hunan Handlike Minimally Invasive Surgery Co., Ltd.. The 510(k) number is K171825.

When did Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument receive FDA 510(k) clearance?

Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument received FDA 510(k) clearance on 2018-02-13, under 510(k) number K171825.

Who is the listed applicant for Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument?

The FDA 510(k) record lists Hunan Handlike Minimally Invasive Surgery Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument?

The FDA product code for Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument is GEI.

Hunan Handlike Minimally Invasive Surgery Co., Ltd.를 신청인으로 등재한 기타 기록

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