510(k) clearance
Drainage Catheter
- 510(k) number
- K254179
- Applicant
- Canyon Medical, Inc.
- Decision date
- Sep 18, 2026
- Date received
- Dec 23, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- FGE
- Device type
- Stents, Drains And Dilators For The Biliary Ducts
- Device class
- Class II
- Regulation
- 21 CFR 876.5010
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Nanjing, CN