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FDA 510(k)

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent

K-Number: K163068 · 2016-12-22

ApplicantQ Urological Corporation
Decision Date2016-12-22
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent is the device name listed in this FDA 510(k) record. The listed applicant is Q Urological Corporation. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K163068. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent?

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Q Urological Corporation. The 510(k) number is K163068.

When did pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent receive FDA 510(k) clearance?

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent received FDA 510(k) clearance on 2016-12-22, under 510(k) number K163068.

Who is the listed applicant for pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent?

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

What is the FDA product code for pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent?

The FDA product code for pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent is FAD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06719089Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral StentRECRUITING

Other records listing Q Urological Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172289pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent

Related Devices (Code: FAD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251890Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd.K251469Endura™ Ureteral Stent and Stent SetCathegenix (Xiamen) Co., Ltd.K243039Ureteral Stents (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.K243830Disposable ureteral stentShenzhen Trious Medical Technology Co., Ltd.K250824Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent SetBoston Scientific CorporationK232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cmUreteral Stent Company

Official Source

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