DeviceClearance

Drainage Catheter— 510(k) K254179

Substantially Equivalent

Canyon Medical, Inc.

FDA 510(k) clearance K254179 for Drainage Catheter, Substantially Equivalent on 2026-09-18. Applicant: Canyon Medical, Inc.. Device class: 2.

Summary

Canyon Medical, Inc. filed a device named only "Drainage Catheter" under product code FGE (Stents, Drains And Dilators For The Biliary Ducts). The name is generic, and the record gives no model or size detail.

Class II, 21 CFR 876.5010. Gastroenterology, Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.

Canyon Medical filed from Nanjing, China. The decision came 269 calendar days after receipt (December 23, 2025 to September 18, 2026).

Clearance details

Applicant
Canyon Medical, Inc.
Product code
Product code FGE
Device class
Class 2
Regulation
21 CFR 876.5010
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Nanjing, CN
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FGE

product code FGE
Death
52
Injury
2,347
Malfunction
9,798
Other
1
Total
12,198

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.