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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 a medical device manufactured by Rocamed Sam. It received FDA 510(k) clearance on 2022-01-26 under approval 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. It is manufactured by Rocamed Sam. The 510(k) number is K212868.

When was JFil Ureteral Stents, JFil Ureteral Stents ECO KIT approved by the FDA?

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

What company makes JFil Ureteral Stents, JFil Ureteral Stents ECO KIT?

JFil Ureteral Stents, JFil Ureteral Stents ECO KIT is manufactured by Rocamed Sam.

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 Clinical Trials

NCT07580963 Stent Related Symptoms Defined by Ureteral Stent Symptom Questionnaire in Patients With Image-Informed Ureteral Stent Lengths NOT_YET_RECRUITING NCT06045962 Optimal Stent Duration After Ureteroscopy ACTIVE_NOT_RECRUITING

Related Devices (Code: FAD)

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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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