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FDA 510(k)

SURGI-CUF REUSABLE, RS SERIES

K-Number: K061962 · 2006-07-25

ApplicantEthox International
Decision Date2006-07-25
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SURGI-CUF REUSABLE, RS SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Ethox International. It received FDA 510(k) clearance on 2006-07-25 under 510(k) number K061962. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGI-CUF REUSABLE, RS SERIES?

SURGI-CUF REUSABLE, RS SERIES is a medical device that received FDA 510(k) clearance on 2006-07-25. The listed applicant is Ethox International. The 510(k) number is K061962.

When did SURGI-CUF REUSABLE, RS SERIES receive FDA 510(k) clearance?

SURGI-CUF REUSABLE, RS SERIES received FDA 510(k) clearance on 2006-07-25, under 510(k) number K061962.

Who is the listed applicant for SURGI-CUF REUSABLE, RS SERIES?

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

What is the FDA product code for SURGI-CUF REUSABLE, RS SERIES?

The FDA product code for SURGI-CUF REUSABLE, RS SERIES is DXQ.

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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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