FDA 510(k)

Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered

K-번호: K163468 · 2017-05-04

결정일2017-05-04

제품 코드MUM

자문 위원회SU

결정Substantially Equivalent

기기 요약

Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2017-05-04 under 510(k) number K163468. The device is classified under product code MUM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered?

Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered is a medical device that received FDA 510(k) clearance on 2017-05-04. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K163468.

When did Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered receive FDA 510(k) clearance?

Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered received FDA 510(k) clearance on 2017-05-04, under 510(k) number K163468.

Who is the listed applicant for Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered?

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

What is the FDA product code for Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered?

The FDA product code for Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered is MUM.

Cook Ireland, Ltd.를 신청인으로 등재한 기타 기록

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)K233079Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)K213946Compass BDS Biliary Stent K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle

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