510(k) clearances

Drainage Catheter

Canyon Medical, Inc. · Gastroenterology, Urology

K254179Substantially EquivalentTraditionalFGE
Open FDA's page for this record
Third party flag
N
City
Nanjing
Advisory committee description
Gastroenterology, Urology
Address 1
Bldg. 3, Phase 2 Accelerator, # 11 Yaogu Ave.
Address 2
Jiangbei New Area
Statement or summary
Summary
Product code
FGE
Zip code
210032
Applicant
Canyon Medical, Inc.
Decision date
2026-09-18
Decision code
SESE
Country code
CN
Device name
Drainage Catheter
Advisory committee
GU
Contact
Huiqi Jiang
K number
K254179
Date received
2025-12-23
Review advisory committee
GU
Postal code
210032
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Stents, Drains And Dilators For The Biliary Ducts
Medical specialty description
Gastroenterology, Urology
Regulation number
876.5010
Device class
2
Registration number
3004129994, 3012480535, 9681442, 3021009035, 3013247477, 3013162291, 3005580113, 3021632375, 3009906660, 3010220595, 1000121056, 3007146453, 3004111573, 1644312, 3014222368, 2126666, 1820334, 3005089785, 3009526575, 3030733800, 1643817, 3010288205, 3031276312, 2020394, 1223925, 9710284, 3015309643, 2134265, 3041276591, 1317547, 2032098, 3008492676, 3030446844, 1319211, 3008146331, 1123137, 9680794, 1531050, 1018233, 3005941719 +107 more
FEI number
3004129994, 3003528016, 3012480535, 3021009035, 3013247477, 3013162291, 3005580113, 3021632375, 3009906660, 3003995201, 3010220595, 1000121056, 3007146453, 3004111573, 2126666, 3014222368, 1820334, 3005089785, 3003565456, 3003084171, 3009526575, 1000123180, 3030733800, 1643817, 3010288205, 3031276312, 2020394, 3015309643, 3041276591, 1317547, 3002807439, 1000122656, 3008492676, 3030446844, 1319211, 3008146331, 3002806565, 1000512168, 1018233, 3002755653 +107 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.