Paguamedicina Structural Hydrogel Pediatric Ureteral Stent, Model NP330-XXX

FDA 510(k) K082805 · Q Urological Corporation

Substantially Equivalent

510(k) numberK082805

Submission

Device name
Paguamedicina Structural Hydrogel Pediatric Ureteral Stent, Model NP330-XXX
Applicant
Q Urological Corporation
Natick, MA, US
Received
September 24, 2008
Decision date
January 20, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FAD – Stent, Ureteral
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4620
Specialty
Gastroenterology, Urology
Implant
Yes

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More from Coloplast Corp.

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K172289pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentFAD · Special 10/04/2017SE
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Questions and answers

When was Paguamedicina Structural Hydrogel Pediatric Ureteral Stent, Model NP330-XXX cleared by the FDA?

Paguamedicina Structural Hydrogel Pediatric Ureteral Stent, Model NP330-XXX (K082805) received a 510(k) decision of Substantially Equivalent on January 20, 2010, 483 days after the submission was received.

What is the product code of K082805?

The FDA product code is FAD – Stent, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.4620.