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FDA 510(k)

Foley Balloon Catheter for Urology

K-Number: K201776 · 2020-12-30

ApplicantApollon Co., Ltd.
Decision Date2020-12-30
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Foley Balloon Catheter for Urology is a medical device manufactured by Apollon Co., Ltd.. It received FDA 510(k) clearance on 2020-12-30 under approval number K201776. 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 Foley Balloon Catheter for Urology?

Foley Balloon Catheter for Urology is a medical device that received FDA 510(k) clearance on 2020-12-30. It is manufactured by Apollon Co., Ltd.. The 510(k) number is K201776.

When was Foley Balloon Catheter for Urology approved by the FDA?

Foley Balloon Catheter for Urology received FDA 510(k) clearance on 2020-12-30, under approval number K201776.

What company makes Foley Balloon Catheter for Urology?

Foley Balloon Catheter for Urology is manufactured by Apollon Co., Ltd..

What is the FDA product code for Foley Balloon Catheter for Urology?

The FDA product code for Foley Balloon Catheter for Urology 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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