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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 the device name listed in this FDA 510(k) record. The listed applicant is Nds Surgical Imaging, LLC. It received FDA 510(k) clearance on 2017-04-07 under 510(k) 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. The listed applicant is Nds Surgical Imaging, LLC. The 510(k) number is K170598.

When did ZeroWire Mobile receive FDA 510(k) clearance?

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

Who is the listed applicant for ZeroWire Mobile?

The FDA 510(k) record lists Nds Surgical Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZeroWire Mobile?

The FDA product code for ZeroWire Mobile is GCJ.

Other records listing Nds Surgical Imaging, LLC 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.

K222890RADIANCE ULTRA 32 4K ZEROWIRE DUOK161228Radiance Ultra Series ZeroWire Embedded

Related Devices (Code: GCJ)

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.

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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.

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