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FDA 510(k)

UROSKOP OMNIA

K-Number: K101491 · 2010-06-30

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2010-06-30
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UROSKOP OMNIA is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2010-06-30 under 510(k) number K101491. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROSKOP OMNIA?

UROSKOP OMNIA is a medical device that received FDA 510(k) clearance on 2010-06-30. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K101491.

When did UROSKOP OMNIA receive FDA 510(k) clearance?

UROSKOP OMNIA received FDA 510(k) clearance on 2010-06-30, under 510(k) number K101491.

Who is the listed applicant for UROSKOP OMNIA?

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

What is the FDA product code for UROSKOP OMNIA?

The FDA product code for UROSKOP OMNIA is JAA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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