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FDA 510(k)

PERCUGUIDE LESION MARKING

K-Number: K920816 · 1992-04-21

ApplicantE-Z-Em, Inc.
Decision Date1992-04-21
Product CodeGDF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PERCUGUIDE LESION MARKING is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 1992-04-21 under 510(k) number K920816. 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 PERCUGUIDE LESION MARKING?

PERCUGUIDE LESION MARKING is a medical device that received FDA 510(k) clearance on 1992-04-21. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K920816.

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

PERCUGUIDE LESION MARKING received FDA 510(k) clearance on 1992-04-21, under 510(k) number K920816.

Who is the listed applicant for PERCUGUIDE LESION MARKING?

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

What is the FDA product code for PERCUGUIDE LESION MARKING?

The FDA product code for PERCUGUIDE LESION MARKING is GDF.

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Other records listing E-Z-Em, Inc. as applicant

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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

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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