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FDA 510(k)

TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT

K-Number: K110971 · 2012-01-10

ApplicantNavotek Medical, Ltd.
Decision Date2012-01-10
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Navotek Medical, Ltd.. It received FDA 510(k) clearance on 2012-01-10 under 510(k) number K110971. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT?

TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT is a medical device that received FDA 510(k) clearance on 2012-01-10. The listed applicant is Navotek Medical, Ltd.. The 510(k) number is K110971.

When did TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT receive FDA 510(k) clearance?

TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT received FDA 510(k) clearance on 2012-01-10, under 510(k) number K110971.

Who is the listed applicant for TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT?

The FDA 510(k) record lists Navotek Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT?

The FDA product code for TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT is IYE.

Related Clinical Trials

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Other records listing Navotek Medical, Ltd. 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.

K100625REALEYE MODEL VCPS

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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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