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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 the device name listed in this FDA 510(k) record. The listed applicant is Emmy Medical, LLC. It received FDA 510(k) clearance on 2018-08-06 under 510(k) 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. The listed applicant is Emmy Medical, LLC. The 510(k) number is K181346.

When did CystoSure Plus Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for CystoSure Plus Catheter?

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

What is the FDA product code for CystoSure Plus Catheter?

The FDA product code for CystoSure Plus Catheter is EZL.

Related Devices (Code: EZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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