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FDA 510(k)

SYRINGE NEEDLE INTRODUCER

K-Number: K901803 · 1990-11-20

ApplicantGlaxo, Inc.
Decision Date1990-11-20
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYRINGE NEEDLE INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Glaxo, Inc.. It received FDA 510(k) clearance on 1990-11-20 under 510(k) number K901803. The device is classified under product code KZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYRINGE NEEDLE INTRODUCER?

SYRINGE NEEDLE INTRODUCER is a medical device that received FDA 510(k) clearance on 1990-11-20. The listed applicant is Glaxo, Inc.. The 510(k) number is K901803.

When did SYRINGE NEEDLE INTRODUCER receive FDA 510(k) clearance?

SYRINGE NEEDLE INTRODUCER received FDA 510(k) clearance on 1990-11-20, under 510(k) number K901803.

Who is the listed applicant for SYRINGE NEEDLE INTRODUCER?

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

What is the FDA product code for SYRINGE NEEDLE INTRODUCER?

The FDA product code for SYRINGE NEEDLE INTRODUCER is KZH.

Related Clinical Trials

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.

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Other records listing Glaxo, Inc. 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.

K954041G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVAL EFFORT FOR EXPENDED NEEDLES)K922187COMPACT SPACERK844169VOLUMATIC

Related Devices (Code: KZH)

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.

K243232GripMateSynthon Hispania S.L.K213429AccuSert Needle InserterEmed Technologies CorporationK163400Orbit InserterYpsomed AGK160860MiniMed Quick-serterMedtronic MinimedK124026LOBSTER AUTO-INJECTORScandinavian Health LimitedK122837AUTOJECT 2 FOR GLASSY SYRINGEOwen Mumford, Ltd.

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.

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