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FDA 510(k)

CystoSure Plus Catheter

K-Number: K181346 · 2018-08-06

ApplicantEmmy Medical, LLC
Decision Date2018-08-06
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CystoSure Plus Catheter is a medical device manufactured by Emmy Medical, LLC. It received FDA 510(k) clearance on 2018-08-06 under approval number K181346. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CystoSure Plus Catheter?

CystoSure Plus Catheter is a medical device that received FDA 510(k) clearance on 2018-08-06. It is manufactured by Emmy Medical, LLC. The 510(k) number is K181346.

When was CystoSure Plus Catheter approved by the FDA?

CystoSure Plus Catheter received FDA 510(k) clearance on 2018-08-06, under approval number K181346.

What company makes CystoSure Plus Catheter?

CystoSure Plus Catheter is manufactured by Emmy Medical, LLC.

What is the FDA product code for CystoSure Plus Catheter?

The FDA product code for CystoSure Plus Catheter is EZL.

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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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