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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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-09-21 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K180029.

When did Malecot Nephrostomy Catheter/Stent Set receive FDA 510(k) clearance?

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

Who is the listed applicant for Malecot Nephrostomy Catheter/Stent Set?

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

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)

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.

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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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