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FDA 510(k)

MICROGUIDE LESION MARKING SYSTEM

K-Number: K923120 · 1992-09-01

ApplicantAngiodynamics, Div. E-Z-Em, Inc.
Decision Date1992-09-01
Product CodeGDF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROGUIDE LESION MARKING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Angiodynamics, Div. E-Z-Em, Inc.. It received FDA 510(k) clearance on 1992-09-01 under 510(k) number K923120. The device is classified under product code GDF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROGUIDE LESION MARKING SYSTEM?

MICROGUIDE LESION MARKING SYSTEM is a medical device that received FDA 510(k) clearance on 1992-09-01. The listed applicant is Angiodynamics, Div. E-Z-Em, Inc.. The 510(k) number is K923120.

When did MICROGUIDE LESION MARKING SYSTEM receive FDA 510(k) clearance?

MICROGUIDE LESION MARKING SYSTEM received FDA 510(k) clearance on 1992-09-01, under 510(k) number K923120.

Who is the listed applicant for MICROGUIDE LESION MARKING SYSTEM?

The FDA 510(k) record lists Angiodynamics, Div. E-Z-Em, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROGUIDE LESION MARKING SYSTEM?

The FDA product code for MICROGUIDE LESION MARKING SYSTEM is GDF.

Related Clinical Trials

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Other records listing Angiodynamics, Div. E-Z-Em, 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.

K961763PULSE*SPRAY INFUSION SYSTEMK951509PULSE*SPRAY INFUSION SYSTEMK951602PULSE*SPRAY INFUSION SYSTEMK950907PULSE*SPRAY INFUSION SYSTEMK933846ANGIOGRAPHY SYRINGE KITS

Related Devices (Code: GDF)

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.

K031173NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013Needle Tech Products, Inc.K950311GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIREGlobal Medical Products, Ltd.K950007SURGICAL INSTRUMENT GUIDEUnited States Surgical, A Division of Tyco HealthcK945124BREAST LESION LOCALIZATION NEEDLEPromex, Inc.K944942BREAST LESION LOCALIZATION NEEDLEPromedical , Ltd.K935538BAUER TEMNO COAXIAL NEEDLEBauer Medical, Inc.

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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