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FDA 510(k)

NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000

K-Number: K050650 · 2005-05-16

ApplicantCytyc Surgical Products
Decision Date2005-05-16
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000 is the device name listed in this FDA 510(k) record. The listed applicant is Cytyc Surgical Products. It received FDA 510(k) clearance on 2005-05-16 under 510(k) number K050650. 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 NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000?

NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000 is a medical device that received FDA 510(k) clearance on 2005-05-16. The listed applicant is Cytyc Surgical Products. The 510(k) number is K050650.

When did NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000 receive FDA 510(k) clearance?

NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000 received FDA 510(k) clearance on 2005-05-16, under 510(k) number K050650.

Who is the listed applicant for NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000?

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

What is the FDA product code for NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000?

The FDA product code for NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000 is GCJ.

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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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