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FDA 510(k)

EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits

K-Number: K251274 · 2026-01-29

ApplicantHR Healthcare
Decision Date2026-01-29
Product CodeEZD
Advisory CommitteeGU
DecisionUnknown

Device Summary

EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits is a medical device manufactured by HR Healthcare. It received FDA 510(k) clearance on 2026-01-29 under approval number K251274. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits?

EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits is a medical device that received FDA 510(k) clearance on 2026-01-29. It is manufactured by HR Healthcare. The 510(k) number is K251274.

When was EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits approved by the FDA?

EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits received FDA 510(k) clearance on 2026-01-29, under approval number K251274.

What company makes EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits?

EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits is manufactured by HR Healthcare.

What is the FDA product code for EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits?

The FDA product code for EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits is EZD.

Related Clinical Trials

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Other Devices by HR Healthcare

K260502Liv Pre-lubricated Intermittent Catheter

Related Devices (Code: EZD)

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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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