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FDA 510(k)

NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X

K-Number: K100195 · 2010-04-21

ApplicantNds Surgical Imaging
Decision Date2010-04-21
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X is the device name listed in this FDA 510(k) record. The listed applicant is Nds Surgical Imaging. It received FDA 510(k) clearance on 2010-04-21 under 510(k) number K100195. 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 NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X?

NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X is a medical device that received FDA 510(k) clearance on 2010-04-21. The listed applicant is Nds Surgical Imaging. The 510(k) number is K100195.

When did NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X receive FDA 510(k) clearance?

NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X received FDA 510(k) clearance on 2010-04-21, under 510(k) number K100195.

Who is the listed applicant for NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X?

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

What is the FDA product code for NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X?

The FDA product code for NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X is GCJ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Nds Surgical Imaging 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.

K131115ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIREK120709THE DOME GX4MP COLOR NONITORK080320PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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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