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FDA 510(k)

Malecot Nephrostomy Catheter/Stent Set

K-Number: K180029 · 2018-09-21

ApplicantCook Incorporated
Decision Date2018-09-21
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Malecot Nephrostomy Catheter/Stent Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-09-21 under approval number K180029. 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 Malecot Nephrostomy Catheter/Stent Set?

Malecot Nephrostomy Catheter/Stent Set is a medical device that received FDA 510(k) clearance on 2018-09-21. It is manufactured by Cook Incorporated. The 510(k) number is K180029.

When was Malecot Nephrostomy Catheter/Stent Set approved by the FDA?

Malecot Nephrostomy Catheter/Stent Set received FDA 510(k) clearance on 2018-09-21, under approval number K180029.

What company makes Malecot Nephrostomy Catheter/Stent Set?

Malecot Nephrostomy Catheter/Stent Set is manufactured by Cook Incorporated.

What is the FDA product code for Malecot Nephrostomy Catheter/Stent Set?

The FDA product code for Malecot Nephrostomy Catheter/Stent Set 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.

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