FDA 510(k)

DUR-8, MODELS DUR-8

K-Number: K012925 · 2001-11-07

Decision Date2001-11-07

Product CodeFGB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

DUR-8, MODELS DUR-8 is the device name listed in this FDA 510(k) record. The listed applicant is Circon Video. It received FDA 510(k) clearance on 2001-11-07 under 510(k) number K012925. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUR-8, MODELS DUR-8?

DUR-8, MODELS DUR-8 is a medical device that received FDA 510(k) clearance on 2001-11-07. The listed applicant is Circon Video. The 510(k) number is K012925.

When did DUR-8, MODELS DUR-8 receive FDA 510(k) clearance?

DUR-8, MODELS DUR-8 received FDA 510(k) clearance on 2001-11-07, under 510(k) number K012925.

Who is the listed applicant for DUR-8, MODELS DUR-8?

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

What is the FDA product code for DUR-8, MODELS DUR-8?

The FDA product code for DUR-8, MODELS DUR-8 is FGB.

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