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FDA 510(k)

BIOTEQ Drainage Catheter Set (One Step Type)

K-Number: K200103 · 2020-10-09

Decision Date2020-10-09
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOTEQ Drainage Catheter Set (One Step Type) is the device name listed in this FDA 510(k) record. The listed applicant is Bioteque Corporation. It received FDA 510(k) clearance on 2020-10-09 under 510(k) number K200103. 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 (One Step Type)?

BIOTEQ Drainage Catheter Set (One Step Type) is a medical device that received FDA 510(k) clearance on 2020-10-09. The listed applicant is Bioteque Corporation. The 510(k) number is K200103.

When did BIOTEQ Drainage Catheter Set (One Step Type) receive FDA 510(k) clearance?

BIOTEQ Drainage Catheter Set (One Step Type) received FDA 510(k) clearance on 2020-10-09, under 510(k) number K200103.

Who is the listed applicant for BIOTEQ Drainage Catheter Set (One Step Type)?

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 (One Step Type)?

The FDA product code for BIOTEQ Drainage Catheter Set (One Step Type) 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.