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FDA 510(k)

ZeroWire Mobile

K-Number: K170598 · 2017-04-07

ApplicantNds Surgical Imaging, LLC
Decision Date2017-04-07
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ZeroWire Mobile is a medical device manufactured by Nds Surgical Imaging, LLC. It received FDA 510(k) clearance on 2017-04-07 under approval number K170598. 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 ZeroWire Mobile?

ZeroWire Mobile is a medical device that received FDA 510(k) clearance on 2017-04-07. It is manufactured by Nds Surgical Imaging, LLC. The 510(k) number is K170598.

When was ZeroWire Mobile approved by the FDA?

ZeroWire Mobile received FDA 510(k) clearance on 2017-04-07, under approval number K170598.

What company makes ZeroWire Mobile?

ZeroWire Mobile is manufactured by Nds Surgical Imaging, LLC.

What is the FDA product code for ZeroWire Mobile?

The FDA product code for ZeroWire Mobile is GCJ.

Other Devices by Nds Surgical Imaging, LLC

K161228Radiance Ultra Series ZeroWire Embedded K222890RADIANCE ULTRA 32 4K ZEROWIRE DUO

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Official Source

View on FDA Database →

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

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