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FDA 510(k)

MEDTRONIC XOMED, INC.

K-Number: K122391 · 2013-01-10

ApplicantMedtronic Xomed, Inc.
Decision Date2013-01-10
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC XOMED, INC. is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2013-01-10 under 510(k) number K122391. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDTRONIC XOMED, INC.?

MEDTRONIC XOMED, INC. is a medical device that received FDA 510(k) clearance on 2013-01-10. The listed applicant is Medtronic Xomed, Inc.. The 510(k) number is K122391.

When did MEDTRONIC XOMED, INC. receive FDA 510(k) clearance?

MEDTRONIC XOMED, INC. received FDA 510(k) clearance on 2013-01-10, under 510(k) number K122391.

Who is the listed applicant for MEDTRONIC XOMED, INC.?

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

What is the FDA product code for MEDTRONIC XOMED, INC.?

The FDA product code for MEDTRONIC XOMED, INC. is LRK.

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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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