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FDA 510(k)

Drainage Catheter

K-Number: K254179 · 2026-09-18

Decision Date2026-09-18
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Drainage Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Canyon Medical, Inc.. It received FDA 510(k) clearance on 2026-09-18 under 510(k) number K254179. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Drainage Catheter?

Drainage Catheter is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is Canyon Medical, Inc.. The 510(k) number is K254179.

When did Drainage Catheter receive FDA 510(k) clearance?

Drainage Catheter received FDA 510(k) clearance on 2026-09-18, under 510(k) number K254179.

Who is the listed applicant for Drainage Catheter?

The FDA 510(k) record lists Canyon Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Drainage Catheter?

The FDA product code for Drainage Catheter is FGE.

Other records listing Canyon Medical, Inc. 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.

Related Devices (Code: FGE)

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.

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