SimPro Now, GentleCath Hydrophilic
K-Number: K223756 · 2023-05-04
ApplicantDentsply Sirona
Decision Date2023-05-04
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
SimPro Now, GentleCath Hydrophilic is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2023-05-04 under approval 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. It is manufactured by Dentsply Sirona. The 510(k) number is K223756.
When was SimPro Now, GentleCath Hydrophilic approved by the FDA?
SimPro Now, GentleCath Hydrophilic received FDA 510(k) clearance on 2023-05-04, under approval number K223756.
What company makes SimPro Now, GentleCath Hydrophilic?
SimPro Now, GentleCath Hydrophilic is manufactured by Dentsply Sirona.
What is the FDA product code for SimPro Now, GentleCath Hydrophilic?
The FDA product code for SimPro Now, GentleCath Hydrophilic is EZD.
Other Devices by Dentsply Sirona
Related Devices (Code: EZD)
K161445PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro CAdapta Medical, Inc.
K160858CompactCath Intermittent Urinary CatheterCompactcath, Inc.
K151745FULL CARE Disposable PVC Nelaton CatheterShaoxing Fuqing Health Products Co., Ltd.
K170233Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)Zhanjiang Star Enterprise Co., Ltd.
K172247Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc.
K181445AMSure Hydrophilic Intermittent CatheterAmsino International, Inc.
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.