FDA 510(k)

EndoSize

K-Number: K160376 · 2016-04-12

Decision Date2016-04-12

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EndoSize is the device name listed in this FDA 510(k) record. The listed applicant is Therenva Sas. It received FDA 510(k) clearance on 2016-04-12 under 510(k) number K160376. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoSize?

EndoSize is a medical device that received FDA 510(k) clearance on 2016-04-12. The listed applicant is Therenva Sas. The 510(k) number is K160376.

When did EndoSize receive FDA 510(k) clearance?

EndoSize received FDA 510(k) clearance on 2016-04-12, under 510(k) number K160376.

Who is the listed applicant for EndoSize?

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

What is the FDA product code for EndoSize?

The FDA product code for EndoSize is LLZ.

Other records listing Therenva Sas as applicant

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.

K222070EndoNaut K212383EndoNaut K171829EndoNaut

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Official Source

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