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FDA 510(k)

CONTINUOUS FLOW Y-TUBING

K-Number: K010122 · 2001-06-04

ApplicantG.U.-Tek
Decision Date2001-06-04
Product CodeLJH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CONTINUOUS FLOW Y-TUBING is the device name listed in this FDA 510(k) record. The listed applicant is G.U.-Tek. It received FDA 510(k) clearance on 2001-06-04 under 510(k) number K010122. The device is classified under product code LJH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTINUOUS FLOW Y-TUBING?

CONTINUOUS FLOW Y-TUBING is a medical device that received FDA 510(k) clearance on 2001-06-04. The listed applicant is G.U.-Tek. The 510(k) number is K010122.

When did CONTINUOUS FLOW Y-TUBING receive FDA 510(k) clearance?

CONTINUOUS FLOW Y-TUBING received FDA 510(k) clearance on 2001-06-04, under 510(k) number K010122.

Who is the listed applicant for CONTINUOUS FLOW Y-TUBING?

The FDA 510(k) record lists G.U.-Tek as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTINUOUS FLOW Y-TUBING?

The FDA product code for CONTINUOUS FLOW Y-TUBING is LJH.

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Related Devices (Code: LJH)

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.

K254111Irrigation/Urology SetsB.Braun Medical, Inc.K162992Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc.K070873AMSURE BLADDER IRRIGATION SETAmsino Intl., Inc.K071832MODIFCATION TO: SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.K063700SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.K062551NEXUS IRRIGATION TUBING SETNexus Medical, LLC

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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