FDA 510(k)

Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)

K-Number: K152619 · 2016-04-29

Decision Date2016-04-29

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) is a medical device manufactured by Prosurg, Inc.. It received FDA 510(k) clearance on 2016-04-29 under approval number K152619. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)?

Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) is a medical device that received FDA 510(k) clearance on 2016-04-29. It is manufactured by Prosurg, Inc.. The 510(k) number is K152619.

When was Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) approved by the FDA?

Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) received FDA 510(k) clearance on 2016-04-29, under approval number K152619.

What company makes Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)?

Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) is manufactured by Prosurg, Inc..

What is the FDA product code for Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)?

The FDA product code for Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) is GCJ.

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Other Devices by Prosurg, Inc.

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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.