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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

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 the device name listed in this FDA 510(k) record. The listed applicant is Bioteque Corporation. It received FDA 510(k) clearance on 2025-12-22 under 510(k) 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. The listed applicant is Bioteque Corporation. The 510(k) number is K251019.

When did BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G receive FDA 510(k) clearance?

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

Who is the listed applicant for BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G?

The FDA 510(k) record lists Bioteque Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Bioteque Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: FGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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