EndoSize

FDA 510(k) K160376 · Therenva Sas

Substantially Equivalent

510(k) numberK160376

Submission

Device name
EndoSize
Applicant
Therenva Sas
Rennes, FR
Received
February 10, 2016
Decision date
April 12, 2016
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was EndoSize cleared by the FDA?

EndoSize (K160376) received a 510(k) decision of Substantially Equivalent on April 12, 2016, 62 days after the submission was received.

What is the product code of K160376?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.