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FDA 510(k)

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

K-Number: K251019 · 2025-12-22

ApplicantBioteque Corporation
Decision Date2025-12-22
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G is a medical device manufactured by Bioteque Corporation. It received FDA 510(k) clearance on 2025-12-22 under approval number K251019. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G?

BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by Bioteque Corporation. The 510(k) number is K251019.

When was BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G approved by the FDA?

BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G received FDA 510(k) clearance on 2025-12-22, under approval number K251019.

What company makes BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G?

BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G is manufactured by Bioteque Corporation.

What is the FDA product code for BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G?

The FDA product code for BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G is FGE.

Related Clinical Trials

NCT04322136 AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural Effusion COMPLETED

Other Devices by Bioteque Corporation

K200103BIOTEQ Drainage Catheter Set (One Step Type) K210419BIOTEQ Drainage Catheter BT-PDS-series

Related Devices (Code: FGE)

K163018Zilver 635 Biliary StentCook Ireland, Ltd. K162404Express SD Biliary Monorail Premounted Stent SystemBoston Scientific Corporation K161203Soehendra Stent RetrieverWilson-Cook Medical, Inc. K150487X-Suit NIR Biliary Metallic StentMedinol, Ltd. K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterWilson-Cook Medical, Inc. K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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