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FDA 510(k)

BREAST LESION LOCALIZATION NEEDLE

K-Number: K945124 · 1994-11-22

ApplicantPromex, Inc.
Decision Date1994-11-22
Product CodeGDF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BREAST LESION LOCALIZATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Promex, Inc.. It received FDA 510(k) clearance on 1994-11-22 under 510(k) number K945124. 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 BREAST LESION LOCALIZATION NEEDLE?

BREAST LESION LOCALIZATION NEEDLE is a medical device that received FDA 510(k) clearance on 1994-11-22. The listed applicant is Promex, Inc.. The 510(k) number is K945124.

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

BREAST LESION LOCALIZATION NEEDLE received FDA 510(k) clearance on 1994-11-22, under 510(k) number K945124.

Who is the listed applicant for BREAST LESION LOCALIZATION NEEDLE?

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

What is the FDA product code for BREAST LESION LOCALIZATION NEEDLE?

The FDA product code for BREAST LESION LOCALIZATION NEEDLE is GDF.

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Other records listing Promex, 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.

K023450BIOPSY SITE TISSUE MARKER DEVICEK022634CO-AXIAL INTRODUCER NEEDLEK010400VACUUM ASSISTED CORE BIOPSY DEVICEK011270AUTOMATED CORE BIOPSY DEVICEK001132BONE BIOPSY NEEDLEK994272AUTOMATED CORE BIOPSY DEVICE

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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 HealthcK944942BREAST LESION LOCALIZATION NEEDLEPromedical , Ltd.K935538BAUER TEMNO COAXIAL NEEDLEBauer Medical, Inc.K935457LOCALIZATION WIRE OR MARKER - SURGICALBip USA, 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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