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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 the device name listed in this FDA 510(k) record. The listed applicant is Endocure Technologies, Inc.. It received FDA 510(k) clearance on 2016-06-07 under 510(k) 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. The listed applicant is Endocure Technologies, Inc.. The 510(k) number is K161147.

When did EndoCure Model EUR078A receive FDA 510(k) clearance?

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

Who is the listed applicant for EndoCure Model EUR078A?

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

What is the FDA product code for EndoCure Model EUR078A?

The FDA product code for EndoCure Model EUR078A is FBN.

Related Devices (Code: FBN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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