FDA.report

510(k) K200260

Device
Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System
Applicant
Boston Scientific Corporation
510(k) number
K200260
Product code
FAD
Decision
Unknown (SESK)
Decision date
2021-04-26
Date received
2020-02-03
Regulation
876.4620
Classification name
Stent, Ureteral
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Heidi Shearer
Address
Three Scimed Pl. Maple Grove MN US 55311 55311

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code FAD

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K243039Ureteral Stents (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.2025-06-18
K243830Disposable ureteral stentShenzhen Trious Medical Technology Co., Ltd.2025-05-14
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K213186NovoFlow Reinforced Ureteral StentColoplast Corp.2022-02-16
K212868JFil Ureteral Stents, JFil Ureteral Stents ECO KITRocamed Sam2022-01-26
K201436Vortek Single Loop Ureteral StentColoplast Corp.2021-02-25
K191446Ureteral Stent Systems, Biliary Drainage CathetersBoston Scientific Corporation2020-01-02
K190659Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed TipAllwin Medical Devices, Inc.2019-12-02
K190312Dornier Ureteral StentDornier Medtech America, Inc.2019-11-15