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FDA 510(k)

Vortek Single Loop Ureteral Stent

K-Number: K201436 · 2021-02-25

ApplicantColoplast Corp.
Decision Date2021-02-25
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Vortek Single Loop Ureteral Stent is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2021-02-25 under 510(k) number K201436. 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 Vortek Single Loop Ureteral Stent?

Vortek Single Loop Ureteral Stent is a medical device that received FDA 510(k) clearance on 2021-02-25. The listed applicant is Coloplast Corp.. The 510(k) number is K201436.

When did Vortek Single Loop Ureteral Stent receive FDA 510(k) clearance?

Vortek Single Loop Ureteral Stent received FDA 510(k) clearance on 2021-02-25, under 510(k) number K201436.

Who is the listed applicant for Vortek Single Loop Ureteral Stent?

The FDA 510(k) record lists Coloplast Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vortek Single Loop Ureteral Stent?

The FDA product code for Vortek Single Loop Ureteral Stent is FAD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07535580Patient-Reported Stent Symptom Outcomes and Migration Rates Following Modified Single-J Ureteric Stent Insertion After UreteroscopyCOMPLETED

Other records listing Coloplast Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P000006Device, impotence, mechanical/hydraulicPMA P020003Prosthesis, testicularK252140Heylo™ SystemK251116Luja CoudéK250270Luja SetK242049SureCath Set

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Related Devices (Code: FAD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251890Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd.K251469Endura™ Ureteral Stent and Stent SetCathegenix (Xiamen) Co., Ltd.K243039Ureteral Stents (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.K243830Disposable ureteral stentShenzhen Trious Medical Technology Co., Ltd.K250824Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent SetBoston Scientific CorporationK232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cmUreteral Stent Company

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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