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FDA 510(k)

Dornier Ureteral Stent

K-Number: K190312 · 2019-11-15

ApplicantDornier Medtech America, Inc.
Decision Date2019-11-15
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Dornier Ureteral Stent is a medical device manufactured by Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2019-11-15 under approval number K190312. 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 Dornier Ureteral Stent?

Dornier Ureteral Stent is a medical device that received FDA 510(k) clearance on 2019-11-15. It is manufactured by Dornier Medtech America, Inc.. The 510(k) number is K190312.

When was Dornier Ureteral Stent approved by the FDA?

Dornier Ureteral Stent received FDA 510(k) clearance on 2019-11-15, under approval number K190312.

What company makes Dornier Ureteral Stent?

Dornier Ureteral Stent is manufactured by Dornier Medtech America, Inc..

What is the FDA product code for Dornier Ureteral Stent?

The FDA product code for Dornier Ureteral Stent is FAD.

Related Clinical Trials

NCT07580963 Stent Related Symptoms Defined by Ureteral Stent Symptom Questionnaire in Patients With Image-Informed Ureteral Stent Lengths NOT_YET_RECRUITING NCT06719089 Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent RECRUITING NCT06045962 Optimal Stent Duration After Ureteroscopy ACTIVE_NOT_RECRUITING NCT07535580 Patient-Reported Stent Symptom Outcomes and Migration Rates Following Modified Single-J Ureteric Stent Insertion After Ureteroscopy COMPLETED

Other Devices by Dornier Medtech America, Inc.

K161771Medilas H Laser Fibers K172084Delta III Lithotripter K190612EQUINOX Balloon Dilatation Catheter K191187Dornier MINNOW Ureteral Catheter K201815Dornier MAGELLAN Ureteral Access Sheath K201074Delta III Lithotripter

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Related Devices (Code: FAD)

K163068pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentQ Urological Corporation 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.

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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