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FDA 510(k)

KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE

K-Number: K900903 · 1990-05-03

ApplicantMilex Products, Inc.
Decision Date1990-05-03
Product CodeGDF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Milex Products, Inc.. It received FDA 510(k) clearance on 1990-05-03 under 510(k) number K900903. 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 KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE?

KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE is a medical device that received FDA 510(k) clearance on 1990-05-03. The listed applicant is Milex Products, Inc.. The 510(k) number is K900903.

When did KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE receive FDA 510(k) clearance?

KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE received FDA 510(k) clearance on 1990-05-03, under 510(k) number K900903.

Who is the listed applicant for KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE?

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

What is the FDA product code for KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE?

The FDA product code for KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE is GDF.

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Other records listing Milex Products, 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.

K001545PIPET CURETK904774INGLAT-O-BALLK904026INFLAT-O-BALLK882628ENDO C BRUSHK862410MILEX KEGEL PERINEAL EXERCISERK861385MILEX BARTHOLIN GLAND CATHETER

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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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