FDA 510(k)

URASSIST

K-Number: K062061 · 2006-10-05

ApplicantPreferred Medical Devices, Inc.

Decision Date2006-10-05

Product CodeNZU

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

URASSIST is the device name listed in this FDA 510(k) record. The listed applicant is Preferred Medical Devices, Inc.. It received FDA 510(k) clearance on 2006-10-05 under 510(k) number K062061. The device is classified under product code NZU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URASSIST?

URASSIST is a medical device that received FDA 510(k) clearance on 2006-10-05. The listed applicant is Preferred Medical Devices, Inc.. The 510(k) number is K062061.

When did URASSIST receive FDA 510(k) clearance?

URASSIST received FDA 510(k) clearance on 2006-10-05, under 510(k) number K062061.

Who is the listed applicant for URASSIST?

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

What is the FDA product code for URASSIST?

The FDA product code for URASSIST is NZU.

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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.