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FDA 510(k)

Urethral Warming Catheter Kit

K-Number: K211149 · 2022-01-05

ApplicantVarian Medical Systems, Inc.
Decision Date2022-01-05
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Urethral Warming Catheter Kit is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2022-01-05 under approval number K211149. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Urethral Warming Catheter Kit?

Urethral Warming Catheter Kit is a medical device that received FDA 510(k) clearance on 2022-01-05. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K211149.

When was Urethral Warming Catheter Kit approved by the FDA?

Urethral Warming Catheter Kit received FDA 510(k) clearance on 2022-01-05, under approval number K211149.

What company makes Urethral Warming Catheter Kit?

Urethral Warming Catheter Kit is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for Urethral Warming Catheter Kit?

The FDA product code for Urethral Warming Catheter Kit is GEH.

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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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