FDA 510(k) clearance · back to tracker

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

Bioteque Corporation cleared K251019 on 2025-12-22, decision: substantially equivalent

K-number

K251019

Sponsor

Bioteque Corporation

Device

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

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-12-22

Product code

FGE

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.5010

Official FDA record

Open K251019on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.