FDA 510(k)

CONTOUR POLARIS URETERAL STENT

K-Number: K010002 · 2001-01-22

Decision Date2001-01-22

Product CodeFAD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

CONTOUR POLARIS URETERAL STENT is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2001-01-22 under 510(k) number K010002. 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 CONTOUR POLARIS URETERAL STENT?

CONTOUR POLARIS URETERAL STENT is a medical device that received FDA 510(k) clearance on 2001-01-22. The listed applicant is Boston Scientific Corp. The 510(k) number is K010002.

When did CONTOUR POLARIS URETERAL STENT receive FDA 510(k) clearance?

CONTOUR POLARIS URETERAL STENT received FDA 510(k) clearance on 2001-01-22, under 510(k) number K010002.

Who is the listed applicant for CONTOUR POLARIS URETERAL STENT?

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

What is the FDA product code for CONTOUR POLARIS URETERAL STENT?

The FDA product code for CONTOUR POLARIS URETERAL STENT is FAD.

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Related Devices (Code: FAD)

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 Corporation K232920RELIEF™ 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.