FDA 510(k)

PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX

K-Number: K082805 · 2010-01-20

Decision Date2010-01-20

Product CodeFAD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX 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 2010-01-20 under 510(k) number K082805. 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 STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX?

PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX is a medical device that received FDA 510(k) clearance on 2010-01-20. The listed applicant is Q Urological Corporation. The 510(k) number is K082805.

When did PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX receive FDA 510(k) clearance?

PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX received FDA 510(k) clearance on 2010-01-20, under 510(k) number K082805.

Who is the listed applicant for PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX?

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 STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX?

The FDA product code for PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX is FAD.

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Related Devices (Code: FAD)

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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.