FDA 510(k)

GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE

K-Number: K950311 · 1995-05-26

Decision Date1995-05-26

Product CodeGDF

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Global Medical Products, Ltd.. It received FDA 510(k) clearance on 1995-05-26 under 510(k) number K950311. 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 GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE?

GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE is a medical device that received FDA 510(k) clearance on 1995-05-26. The listed applicant is Global Medical Products, Ltd.. The 510(k) number is K950311.

When did GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE receive FDA 510(k) clearance?

GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE received FDA 510(k) clearance on 1995-05-26, under 510(k) number K950311.

Who is the listed applicant for GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE?

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

What is the FDA product code for GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE?

The FDA product code for GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE is GDF.

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Other records listing Global Medical Products, Ltd. as applicant

K962821EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT K961444GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725)K951448GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE K951421GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES

Related Devices (Code: GDF)

K031173NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013Needle Tech Products, Inc.K950007SURGICAL INSTRUMENT GUIDEUnited States Surgical, A Division of Tyco Healthc K945124BREAST LESION LOCALIZATION NEEDLEPromex, Inc.K944942BREAST LESION LOCALIZATION NEEDLEPromedical , Ltd.K935538BAUER TEMNO COAXIAL NEEDLEBauer Medical, Inc.K935457LOCALIZATION WIRE OR MARKER - SURGICALBip USA, 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.