FDA 510(k)

SimPro™ Now, GentleCath™ Hydrophilic

K-Number: K223756 · 2023-05-04

Decision Date2023-05-04

Product CodeEZD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SimPro™ Now, GentleCath™ Hydrophilic is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K223756. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SimPro™ Now, GentleCath™ Hydrophilic?

SimPro™ Now, GentleCath™ Hydrophilic is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Dentsply Sirona. The 510(k) number is K223756.

When did SimPro™ Now, GentleCath™ Hydrophilic receive FDA 510(k) clearance?

SimPro™ Now, GentleCath™ Hydrophilic received FDA 510(k) clearance on 2023-05-04, under 510(k) number K223756.

Who is the listed applicant for SimPro™ Now, GentleCath™ Hydrophilic?

The FDA 510(k) record lists Dentsply Sirona as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SimPro™ Now, GentleCath™ Hydrophilic?

The FDA product code for SimPro™ Now, GentleCath™ Hydrophilic is EZD.

Other records listing Dentsply Sirona as applicant

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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.