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FDA 510(k)

Black Silicone Filiform Double Pigtail Stent Set

K-Number: K172017 · 2018-03-26

Decision Date2018-03-26
Product CodeFAD
Advisory CommitteeGU
DecisionUnknown

Device Summary

Black Silicone Filiform Double Pigtail 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 2018-03-26 under 510(k) number K172017. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Black Silicone Filiform Double Pigtail Stent Set?

Black Silicone Filiform Double Pigtail Stent Set is a medical device that received FDA 510(k) clearance on 2018-03-26. The listed applicant is Cook Incorporated. The 510(k) number is K172017.

When did Black Silicone Filiform Double Pigtail Stent Set receive FDA 510(k) clearance?

Black Silicone Filiform Double Pigtail Stent Set received FDA 510(k) clearance on 2018-03-26, under 510(k) number K172017.

Who is the listed applicant for Black Silicone Filiform Double Pigtail 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 Black Silicone Filiform Double Pigtail Stent Set?

The FDA product code for Black Silicone Filiform Double Pigtail Stent Set is FAD.

Related Clinical Trials

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.

Other records listing Cook Incorporated as applicant

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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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.

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.