K251019

BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G

510(k) number: K251019
Device name: BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
Applicant: Bioteque Corporation TW
Product code: FGE — Stents, Drains And Dilators For The Biliary Ducts
Decision date: 2025-12-22
Date received: 2025-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Gastroenterology, Urology

Also available from FDA: K251019.pdf

Official FDA record: K251019

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.