FDA 510(k)

RESONANCE METALLIC URETERAL STENT

K-Number: K063742 · 2007-05-08

Decision Date2007-05-08

Product CodeFAD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

RESONANCE METALLIC URETERAL STENT is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2007-05-08 under 510(k) number K063742. 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 RESONANCE METALLIC URETERAL STENT?

RESONANCE METALLIC URETERAL STENT is a medical device that received FDA 510(k) clearance on 2007-05-08. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K063742.

When did RESONANCE METALLIC URETERAL STENT receive FDA 510(k) clearance?

RESONANCE METALLIC URETERAL STENT received FDA 510(k) clearance on 2007-05-08, under 510(k) number K063742.

Who is the listed applicant for RESONANCE METALLIC URETERAL STENT?

The FDA 510(k) record lists Cook Ireland, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESONANCE METALLIC URETERAL STENT?

The FDA product code for RESONANCE METALLIC URETERAL STENT is FAD.

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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.