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FDA 510(k)

JFil Ureteral Stents, JFil Ureteral Stents ECO KIT

K-Number: K212868 · 2022-01-26

ApplicantRocamed Sam
Decision Date2022-01-26
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

JFil Ureteral Stents, JFil Ureteral Stents ECO KIT is the device name listed in this FDA 510(k) record. The listed applicant is Rocamed Sam. It received FDA 510(k) clearance on 2022-01-26 under 510(k) number K212868. 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 JFil Ureteral Stents, JFil Ureteral Stents ECO KIT?

JFil Ureteral Stents, JFil Ureteral Stents ECO KIT is a medical device that received FDA 510(k) clearance on 2022-01-26. The listed applicant is Rocamed Sam. The 510(k) number is K212868.

When did JFil Ureteral Stents, JFil Ureteral Stents ECO KIT receive FDA 510(k) clearance?

JFil Ureteral Stents, JFil Ureteral Stents ECO KIT received FDA 510(k) clearance on 2022-01-26, under 510(k) number K212868.

Who is the listed applicant for JFil Ureteral Stents, JFil Ureteral Stents ECO KIT?

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

What is the FDA product code for JFil Ureteral Stents, JFil Ureteral Stents ECO KIT?

The FDA product code for JFil Ureteral Stents, JFil Ureteral Stents ECO KIT is FAD.

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

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

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