Ultrathane Endoureterotomy Stent Set
K-Number: K160891 · 2016-06-24
ApplicantCook Incorporated
Decision Date2016-06-24
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Ultrathane Endoureterotomy Stent Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2016-06-24 under approval number K160891. 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 Ultrathane Endoureterotomy Stent Set?
Ultrathane Endoureterotomy Stent Set is a medical device that received FDA 510(k) clearance on 2016-06-24. It is manufactured by Cook Incorporated. The 510(k) number is K160891.
When was Ultrathane Endoureterotomy Stent Set approved by the FDA?
Ultrathane Endoureterotomy Stent Set received FDA 510(k) clearance on 2016-06-24, under approval number K160891.
What company makes Ultrathane Endoureterotomy Stent Set?
Ultrathane Endoureterotomy Stent Set is manufactured by Cook Incorporated.
What is the FDA product code for Ultrathane Endoureterotomy Stent Set?
The FDA product code for Ultrathane Endoureterotomy Stent Set is FAD.
Other Devices by Cook Incorporated
Related Devices (Code: FAD)
K163068pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentQ Urological Corporation
K161277ConvertX Nephroureteral Stent SystemBrightwater Medical
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.