Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EndoCure Model EUR078A

K-Number: K161147 · 2016-06-07

ApplicantEndocure Technologies, Inc.
Decision Date2016-06-07
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EndoCure Model EUR078A is a medical device manufactured by Endocure Technologies, Inc.. It received FDA 510(k) clearance on 2016-06-07 under approval number K161147. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoCure Model EUR078A?

EndoCure Model EUR078A is a medical device that received FDA 510(k) clearance on 2016-06-07. It is manufactured by Endocure Technologies, Inc.. The 510(k) number is K161147.

When was EndoCure Model EUR078A approved by the FDA?

EndoCure Model EUR078A received FDA 510(k) clearance on 2016-06-07, under approval number K161147.

What company makes EndoCure Model EUR078A?

EndoCure Model EUR078A is manufactured by Endocure Technologies, Inc..

What is the FDA product code for EndoCure Model EUR078A?

The FDA product code for EndoCure Model EUR078A is FBN.

Related Devices (Code: FBN)

K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital ControllerBoston Scientific Corporation K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation K231105Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)Shanghai AnQing Medical Instrument Co., Ltd. K223741Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)Zhuhai Pusen Medical Technology Co., Ltd. K222261Flexible Video-Choledochoscope SystemShanghai SeeGen Photoelectric Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑