FDA 510(k)

Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)

Numéro K : K170233 · 2017-10-13

DemandeurZhanjiang Star Enterprise Co., Ltd.

Date de décision2017-10-13

Code produitEZD

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) is the device name listed in this FDA 510(k) record. The listed applicant is Zhanjiang Star Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K170233. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)?

Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Zhanjiang Star Enterprise Co., Ltd.. The 510(k) number is K170233.

When did Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) receive FDA 510(k) clearance?

Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) received FDA 510(k) clearance on 2017-10-13, under 510(k) number K170233.

Who is the listed applicant for Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)?

The FDA 510(k) record lists Zhanjiang Star Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)?

The FDA product code for Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) is EZD.

Essais cliniques associés

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Autres dossiers indiquant Zhanjiang Star Enterprise Co., Ltd. en tant que demandeur

K170234Endotracheal tube; Reinforced Endotracheal tube

Dispositifs connexes (Code : EZD)

K261418Liquick X-treme, Liquick X-treme PlusTeleflex Medical K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).Convatec K261658Base de lancette réutilisable LoFric Origo Pro CoudéWellspect AB K262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated

Source officielle

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