FDA 510(k)

네오스코프 3D - 3D 디지털 비디오 내시 시스템 (고정형/유연형)

K-번호: K152619 · 2016-04-29

결정일2016-04-29

제품 코드GCJ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) is the device name listed in this FDA 510(k) record. The listed applicant is Prosurg, Inc.. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K152619. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)?

Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Prosurg, Inc.. The 510(k) number is K152619.

When did Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) receive FDA 510(k) clearance?

Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) received FDA 510(k) clearance on 2016-04-29, under 510(k) number K152619.

Who is the listed applicant for Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)?

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

What is the FDA product code for Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)?

The FDA product code for Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) is GCJ.

Prosurg, Inc.를 신청인으로 등재한 기타 기록

K152511Neo - 관절내시경 (고정형) 2.0mm/3.5mm, 외피/캘리라, 외피/캘리라 + 핸들, 외피/캘리라를 위한 트로카르 K152466neo-bron초스코프 - 디지털 비디오 bron초스코피 시스템(고정형/유연형)

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