EnVisio Navigation Sytem

FDA 510(k) K183400 · Elucent Medical, Inc.

Substantially Equivalent

510(k) numberK183400

Submission

Device name
EnVisio Navigation Sytem
Applicant
Elucent Medical, Inc.
Eden Prairie, MN, US
Received
December 7, 2018
Decision date
March 22, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NEU – Marker, Radiographic, Implantable
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4300
Specialty
General, Plastic Surgery
Implant
Yes

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Questions and answers

When was EnVisio Navigation Sytem cleared by the FDA?

EnVisio Navigation Sytem (K183400) received a 510(k) decision of Substantially Equivalent on March 22, 2019, 105 days after the submission was received.

What is the product code of K183400?

The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.