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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 a medical device manufactured by Q Urological Corporation. It received FDA 510(k) clearance on 2016-12-22 under approval 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. It is manufactured by Q Urological Corporation. The 510(k) number is K163068.

When was pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent approved by the FDA?

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

What company makes pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent?

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent is manufactured by Q Urological Corporation.

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

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Other Devices by Q Urological Corporation

K172289pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent

Related Devices (Code: FAD)

K161277ConvertX Nephroureteral Stent SystemBrightwater Medical K160891Ultrathane Endoureterotomy Stent SetCook Incorporated K151051Universa Soft Ureteral Stents and Stent SetsCook Incorporated K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTSColoplast Corp. K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTSColoplast Corp. K172289pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentQ Urological Corporation

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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