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FDA 510(k)

Silicone Foley Catheter for single use

K-Number: K172807 · 2018-06-04

ApplicantChangzhou Rongxin Medicine Minimal Invasion Technology
Decision Date2018-06-04
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Silicone Foley Catheter for single use is a medical device manufactured by Changzhou Rongxin Medicine Minimal Invasion Technology. It received FDA 510(k) clearance on 2018-06-04 under approval number K172807. 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 Silicone Foley Catheter for single use?

Silicone Foley Catheter for single use is a medical device that received FDA 510(k) clearance on 2018-06-04. It is manufactured by Changzhou Rongxin Medicine Minimal Invasion Technology. The 510(k) number is K172807.

When was Silicone Foley Catheter for single use approved by the FDA?

Silicone Foley Catheter for single use received FDA 510(k) clearance on 2018-06-04, under approval number K172807.

What company makes Silicone Foley Catheter for single use?

Silicone Foley Catheter for single use is manufactured by Changzhou Rongxin Medicine Minimal Invasion Technology.

What is the FDA product code for Silicone Foley Catheter for single use?

The FDA product code for Silicone Foley Catheter for single use 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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