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FDA 510(k)

NORTHGATE FLOW ASSIST TUBING FOR UROLOGY

K-Number: K943361 · 1995-09-29

ApplicantNorthgate Technologies, Inc.
Decision Date1995-09-29
Product CodeLJH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NORTHGATE FLOW ASSIST TUBING FOR UROLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Northgate Technologies, Inc.. It received FDA 510(k) clearance on 1995-09-29 under 510(k) number K943361. 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 NORTHGATE FLOW ASSIST TUBING FOR UROLOGY?

NORTHGATE FLOW ASSIST TUBING FOR UROLOGY is a medical device that received FDA 510(k) clearance on 1995-09-29. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K943361.

When did NORTHGATE FLOW ASSIST TUBING FOR UROLOGY receive FDA 510(k) clearance?

NORTHGATE FLOW ASSIST TUBING FOR UROLOGY received FDA 510(k) clearance on 1995-09-29, under 510(k) number K943361.

Who is the listed applicant for NORTHGATE FLOW ASSIST TUBING FOR UROLOGY?

The FDA 510(k) record lists Northgate Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORTHGATE FLOW ASSIST TUBING FOR UROLOGY?

The FDA product code for NORTHGATE FLOW ASSIST TUBING FOR UROLOGY 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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